NeoplasmsPhase 2NCT06926673
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3
A Phase 2 study testing Dostarlimab, Belrestotug. and Nelistotug in people with Neoplasms, run by GlaxoSmithKline at 15 sites in 6 countries.
Trial summary
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess safety and pharmacokinetics and pharmacodynamics (PK/PD) of novel regimens (Dostarlimab plus belrestotug , and Dostarlimab plus belrestotug plus nelistotug) in participants with previously treated NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Dostarlimab, Belrestotug. and Nelistotug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 23 Dec 2021to 2 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants capable of giving signed informed consent/assent.
- Male or female, aged 18 years or older at the time consent is obtained.
- Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
- Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen.
- Participants with known V-Raf Murine Sarcoma Viral Oncogene Homolog B (BRAF) molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
- Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
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- Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
- Adequate organ function as defined in the protocol.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP) as defined in the protocol or ii) A WOCBP who agrees to follow the protocol defined contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- Life expectancy of at least 12 weeks.
Who cannot join
- Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
- Docetaxel at any time.
- Any of the investigational agents being tested in the current study.
- Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug administered.
- Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
- Received greater than (>) 2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
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- Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years.
- Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
- Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
- Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
- Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment. Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) are permitted.
- Prior allogeneic/autologous bone marrow or solid organ transplantation.
- Receipt of any live vaccine within 30 days prior to first dose of study treatment.
- Toxicity from previous anticancer treatment that includes:
- 1. Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation.
- 2. History of myocarditis of any grade during a previous treatment with immunotherapy 3. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).
- History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for pastpneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
- Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
- Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
- History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include
- Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block.
- Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.
- Symptomatic pericarditis.
- Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
- Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
- Participants with known human immunodeficiency virus infection.
- Participants with history of severe hypersensitivity to mAbs or hypersensitivity to any of the study treatment(s) or their excipients.
- Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
- Pregnant or lactating female participants.
- Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
- Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
- Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
- Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.
- Known hypersensitivity to components or excipients of dostarlimab, belrestotug, and/or nelistotug
- Has received prior antibodies or drugs targeting TIGIT, CD96, PVRIG, or other therapies targeting the CD226 axis pathway
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
France4 sites
GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Paris, 75018
GSK Investigational Site
Paris, 75248
GSK Investigational Site
Villejuif, 94805
Canada3 sites
GSK Investigational Site
Brampton, Ontario, L6R 3J7
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Toronto, Ontario, M5G 2M9
Italy3 sites
GSK Investigational Site
Meldola FC, 47014
GSK Investigational Site
Milan, 20133
GSK Investigational Site
Siena, 53100
Spain3 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Málaga, 29010
United States1 site
GSK Investigational SIte
Nashville, Tennessee, 37203
About this study
Official title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess safety and pharmacokinetics and pharmacodynamics (PK/PD) of novel regimens (Dostarlimab plus belrestotug , and Dostarlimab plus belrestotug plus nelistotug) in participants with previously treated NSCLC.
- Conditions
- Neoplasms
- Being tested
- Dostarlimab, Belrestotug., Nelistotug
- Keywords
- NSCLC, Dostarlimab, Belrestotug, Nelistotug
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Dostarlimab will be administered
Belrestotug.Drug
Belrestotug will be administered
NelistotugDrug
Nelistotug will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab plus Belrestotug | Experimental | Not described Receives: Drug: Dostarlimab; Drug: Belrestotug. |
| Dostarlimab plus Belrestotug plus Nelistotug | Experimental | Not described Receives: Drug: Dostarlimab; Drug: Belrestotug.; Drug: Nelistotug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities.
Measured: Up to 21 days
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants Who Received Concomitant Medications (Arm 4)
Number of participants who received Concomitant medications is summarized.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants Who Received Concomitant Medications (Arm 5)
Number of participants who received Concomitant medications is summarized.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Measured: Up to approximately 107 weeks
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Up to approximately 97 weeks
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Up to approximately 107 weeks
Part 2: Overall Survival (OS)
OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death.
Measured: Up to approximately 107 weeks
Secondary outcomes (24)
Part 1: Objective Response Rate (ORR) (Arm 4)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Measured: Up to approximately 97 weeks
Part 1: Objective Response Rate (ORR) (Arm 5)
ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria per RECIST version 1.1. CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Measured: Up to approximately 107 weeks
Part 1: Disease Control Rate (DCR) (Arm 4)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Measured: Up to approximately 97 weeks
Part 1: Disease Control Rate (DCR) (Arm 5)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Measured: Up to approximately 107 weeks
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Measured: Up to 21 days (Cycle 1)
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Measured: Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Measured: Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Measured: Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Nelistotug.
Measured: Up to 21 days (Cycle 1)
Part 2: Survival Rate at 12 and 18 Months
Survival rate was planned to be anaysed at 12 and 18 months
Measured: At 12 and 18 months
Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)
CR, PR, SD and PD was planned to be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Measured: Up to approximately 107 weeks
Part 2: Progression-free Survival (PFS)
PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Measured: Up to approximately 107 weeks
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per RECIST version 1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Measured: Up to approximately 107 weeks
Part 2: Duration of Response (DOR)
DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: Up to approximately 107 weeks
Part 2: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Measured: Up to approximately 107 weeks
Part 2: Number of Participants With Immune-based (i) Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), and Stable Disease (iSD)
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST is used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
Measured: Up to approximately 107 weeks
Part 2: Progression-free Survival (iPFS)
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Measured: Up to approximately 107 weeks
Part 2: Objective Response Rate (iORR)
iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: Up to approximately 107 weeks
Part 2: Duration of Response (iDOR)
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: Up to approximately 107 weeks
Part 2: Number of Participants With AEs, SAEs, Adverse Events of Special Interest (AESI), AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. AEs were planned to be coded using the MedDRA coding system.
Measured: Up to approximately 107 weeks
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs and Laboratory Parameters
Clinically significant changes in vital signs were planned to be assessed. Blood samples were planned to be collected for the analysis of laboratory parameters.
Measured: Up to approximately 107 weeks
Part 2: Cmax and Cmin for Dostarlimab
Blood samples were planned to be collected to assess the pharmacokinetics of Dostarlimab.
Measured: Up to approximately 107 weeks
Part 2: Cmax and Cmin for Belrestotug
Blood samples were planned to be collected to assess the pharmacokinetics of Belrestotug.
Measured: Up to approximately 107 weeks
Part 2: Number of Participants With Positive Anti-drug Antibodies (ADA)
Serum samples were planned to be collected for the analysis of the presence of ADAs using validated immunoassays.
Measured: Up to approximately 107 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2025
- Study start23 Dec 2021
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926673
- Sponsor's protocol ID
- 205801-003
- Other IDs
- 2018-001316-29, 2018
- Status last verified
- Jun 2025
- First submitted
- 11 Apr 2025
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
- ClinicalTrials.gov ID
- NCT06926673
- Acronym / sponsor ID
- 205801-003
- Conditions
- Neoplasms
- Keywords
- NSCLC, Dostarlimab, Belrestotug, Nelistotug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 14 Apr 2025 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess safety and pharmacokinetics and pharmacodynamics (PK/PD) of novel regimens (Dostarlimab plus belrestotug , and Dostarlimab plus belrestotug plus nelistotug) in participants with previously treated NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab plus Belrestotug | Experimental | Drug: Dostarlimab, Drug: Belrestotug. |
| Dostarlimab plus Belrestotug plus Nelistotug | Experimental | Drug: Dostarlimab, Drug: Belrestotug., Drug: Nelistotug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants capable of giving signed informed consent/assent.
- Male or female, aged 18 years or older at the time consent is obtained.
- Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
- Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
Key exclusion criteria (36 listed)
- Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
- Docetaxel at any time.
- Any of the investigational agents being tested in the current study.
- Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug administered.
- Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabDostarlimab will be administered | Drug | Dostarlimab plus Belrestotug, Dostarlimab plus Belrestotug plus Nelistotug |
| Belrestotug.Belrestotug will be administered | Drug | Dostarlimab plus Belrestotug, Dostarlimab plus Belrestotug plus Nelistotug |
| NelistotugNelistotug will be administered. | Drug | Dostarlimab plus Belrestotug plus Nelistotug |
Primary outcome
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
Time frame: Up to approximately 97 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
Time frame: Up to approximately 107 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)
Time frame: Up to 21 days
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities.
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Time frame: Up to approximately 97 weeks
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Time frame: Up to approximately 107 weeks
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Time frame: Up to approximately 97 weeks
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead.
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Time frame: Up to approximately 107 weeks
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Time frame: Up to approximately 97 weeks
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Time frame: Up to approximately 107 weeks
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants Who Received Concomitant Medications (Arm 4)
Time frame: Up to approximately 97 weeks
Number of participants who received Concomitant medications is summarized.
Part 1: Number of Participants Who Received Concomitant Medications (Arm 5)
Time frame: Up to approximately 107 weeks
Number of participants who received Concomitant medications is summarized.
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Time frame: Up to approximately 97 weeks
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Time frame: Up to approximately 107 weeks
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
Time frame: Up to approximately 97 weeks
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
Time frame: Up to approximately 107 weeks
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
Time frame: Up to approximately 97 weeks
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
Time frame: Up to approximately 107 weeks
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Time frame: Up to approximately 97 weeks
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Time frame: Up to approximately 107 weeks
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Time frame: Up to approximately 97 weeks
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Time frame: Up to approximately 107 weeks
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Time frame: Up to approximately 97 weeks
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Time frame: Up to approximately 107 weeks
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Time frame: Up to approximately 97 weeks
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Time frame: Up to approximately 107 weeks
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 2: Overall Survival (OS)
Time frame: Up to approximately 107 weeks
OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death.
24 secondary outcomes
Part 1: Objective Response Rate (ORR) (Arm 4)
Time frame: Up to approximately 97 weeks
Part 1: Objective Response Rate (ORR) (Arm 5)
Time frame: Up to approximately 107 weeks
Part 1: Disease Control Rate (DCR) (Arm 4)
Time frame: Up to approximately 97 weeks
Part 1: Disease Control Rate (DCR) (Arm 5)
Time frame: Up to approximately 107 weeks
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Time frame: Up to 21 days (Cycle 1)
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Time frame: Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Time frame: Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Time frame: Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Time frame: Up to 21 days (Cycle 1)
Part 2: Survival Rate at 12 and 18 Months
Time frame: At 12 and 18 months
Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)
Time frame: Up to approximately 107 weeks
Part 2: Progression-free Survival (PFS)
Time frame: Up to approximately 107 weeks
Part 2: Objective Response Rate (ORR)
Time frame: Up to approximately 107 weeks
Part 2: Duration of Response (DOR)
Time frame: Up to approximately 107 weeks
Part 2: Disease Control Rate (DCR)
Time frame: Up to approximately 107 weeks
Part 2: Number of Participants With Immune-based (i) Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), and Stable Disease (iSD)
Time frame: Up to approximately 107 weeks
Part 2: Progression-free Survival (iPFS)
Time frame: Up to approximately 107 weeks
Part 2: Objective Response Rate (iORR)
Time frame: Up to approximately 107 weeks
Part 2: Duration of Response (iDOR)
Time frame: Up to approximately 107 weeks
Part 2: Number of Participants With AEs, SAEs, Adverse Events of Special Interest (AESI), AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
Time frame: Up to approximately 107 weeks
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs and Laboratory Parameters
Time frame: Up to approximately 107 weeks
Part 2: Cmax and Cmin for Dostarlimab
Time frame: Up to approximately 107 weeks
Part 2: Cmax and Cmin for Belrestotug
Time frame: Up to approximately 107 weeks
Part 2: Number of Participants With Positive Anti-drug Antibodies (ADA)
Time frame: Up to approximately 107 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dostarlimab, Belrestotug. and Nelistotug in people with Neoplasms, run by GlaxoSmithKline at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Canada, Italy, Spain, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) (time frame: Up to approximately 97 weeks). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.