Lung CancerPhase 2NCT06749886
An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting
A Phase 2 study testing Denosumab, tislelizumab and Docetaxel in people with Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Denosumab, tislelizumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age≥ 18 years old;
- Patients with histologically or cytologically confirmed non-bone metastases stage IV NSCLC;
- EGFR, ALK, and ROS1 are all wild-type (for other driver genes, if there is no first-line approval for corresponding targeted therapy or if the patient refuses targeted therapy, these patients are allowed to be enrolled);
- first-line treatment with immune checkpoint inhibitors and clinical benefit (PFS ≥ 3 months);
- Have measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, the short diameter of CT scan of lymph node lesions is ≥15mm, and the thickness of the scanning layer is not more than 5mm, and the measurable lesions have not received local treatment such as radiotherapy and cryotherapy);
- ECOG PS: 0-2 points;
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- Estimated survival time≥ 3 months;
- Adequate hematologic function, defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 90g/L (no history of blood transfusion within 7 days, not corrected with G-CSF and other hematopoietic stimulating factors);
- adequate liver function, defined as total bilirubin levels ≤1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases, AST and ALT levels ≤ 5 times ULN;
- adequate renal function, defined as creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
- Adequate coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
- For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug, and if the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required;
- If there is a risk of conception, male and female patients need to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment (Note: abstinence can be accepted as a contraceptive method if abstinence is the subject's usual lifestyle and preferred contraceptive method);
- Subjects voluntarily joined this study, signed a written informed consent form before the implementation of any trial-related procedures, had good compliance, and cooperated with follow-up.
Who cannot join
- Patients on first-line docetaxel chemotherapy;
- Patients with symptomatic brain metastases (symptoms of brain metastases remain clinically stable for at least 1 month after treatment, and no steroids and anticonvulsants can be enrolled for at least 1 month before entering the study);
- Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in effusion can be enrolled);
- have not recovered adequately from toxicity and/or complications caused by any intervention (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);
- Diagnosis of other malignant tumors within 5 years before the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ that has undergone radical resection, if other malignant tumors or lung cancer are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent metastatic lesions is required;
- Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention;
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- Received solid organ or blood system transplantation;
- Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia;
- Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy;
- Patients who need long-term systemic use of corticosteroids (patients who need intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroids due to COPD and asthma can be enrolled);
- History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year before the first dose;
- Have an active infection requiring treatment or have used systemic anti-infective drugs within one week before the first dose;
- Known psychiatric illness or substance abuse that may affect compliance with trial requirements;
- Those who are considered unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Chunxia Su, 13601899076, susu_mail@126.com
Chunxia Su, doctor
About this study
The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced NSCLC.
Primary endpoint:
Read more
progression-free survival (PFS) assessed by investigators according to RECIST 1.1;
Secondary endpoint:
- Overall survival (OS) assessed by investigators according to RECIST 1.1;
- Objective response rate (ORR) assessed by investigators according to RECIST 1.1;
- Disease control rate (DCR) assessed by investigators according to RECIST 1.1;
- Duration of response (DOR) assessed by investigators according to RECIST 1.1;
Exploratory endpoint:
bone metastasis-free survival.
Participants will receive denosumab combined with tislelizumab and docetaxel.
- Conditions
- Lung Cancer
- Being tested
- Denosumab, tislelizumab, Docetaxel
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Denosumab, 120 mg subcutaneous injection, every 21-28 days a cycle, given on the first day, a loading dose is given on d8 of the first cycle, and continued use
tislelizumabDrug
Tislelizumab, 200 mg intravenous infusion, every 21 days a cycle, given on the first day, and continued use
DocetaxelDrug
Docetaxel, 60 mg/m2 intravenous infusion, every 21 days a cycle, given on the first day, and continued use.
| Study group | Role | What they receive |
|---|---|---|
| cohort1 | Experimental | The subjects in this cohort will receive denosumab combined with tislelizumab and docetaxel. Receives: Drug: Denosumab; Drug: tislelizumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival
Progression-free survival refers to the time from the start of combined treatment to any objectively documented tumor progression or patient death (the last follow-up date for patients lost to follow-up; the end of follow-up date for patients still alive at the end of the study).
Measured: up to 24 months
Secondary outcomes (4)
overall survival
Overall survival (OS): the time from the first dose to death from any cause (the last follow-up date for patients who were lost to follow-up; the end of follow-up date for patients who were still alive at the end of the study)
Measured: up to 24 months
objective response rate
Objective response rate (ORR) refers to the proportion of patients whose tumors shrink to a certain amount and remain so for a certain period of time, including cases of complete remission (CR) and partial remission (PR).
Measured: 12 months
Disease control rate
Disease control rate (DCR): refers to the proportion of patients whose tumors shrink to a certain amount and remain so for a certain period of time, including cases of complete remission (CR), partial remission (PR) and stable disease (SD).
Measured: 12 months
Duration of remission
Duration of response (DOR): refers to the duration from the first recorded confirmed response (CR or PR) to the first recorded disease progression (PD) or death due to any cause (whichever occurs first).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start19 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxia Su, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749886
- Sponsor's protocol ID
- 2024LY0208
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting
- ClinicalTrials.gov ID
- NCT06749886
- Acronym / sponsor ID
- 2024LY0208
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced NSCLC.
Primary endpoint:
progression-free survival (PFS) assessed by investigators according to RECIST 1.1;
Secondary endpoint:
- Overall survival (OS) assessed by investigators according to RECIST 1.1;
- Objective response rate (ORR) assessed by investigators according to RECIST 1.1;
- Disease control rate (DCR) assessed by investigators according to RECIST 1.1;
- Duration of response (DOR) assessed by investigators according to RECIST 1.1;
Exploratory endpoint:
bone metastasis-free survival.
Participants will receive denosumab combined with tislelizumab and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort1 | Experimental | Drug: Denosumab, Drug: tislelizumab, Drug: DocetaxelThe subjects in this cohort will receive denosumab combined with tislelizumab and docetaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age≥ 18 years old;
- Patients with histologically or cytologically confirmed non-bone metastases stage IV NSCLC;
- EGFR, ALK, and ROS1 are all wild-type (for other driver genes, if there is no first-line approval for corresponding targeted therapy or if the patient refuses targeted therapy, these patients are allowed to be enrolled);
- first-line treatment with immune checkpoint inhibitors and clinical benefit (PFS ≥ 3 months);
- Have measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, the short diameter of CT scan of lymph node lesions is ≥15mm, and the thickness of the scanning layer is not more than 5mm, and the measurable lesions have not received local treatment such as radiotherapy and cryotherapy);
Key exclusion criteria (14 listed)
- Patients on first-line docetaxel chemotherapy;
- Patients with symptomatic brain metastases (symptoms of brain metastases remain clinically stable for at least 1 month after treatment, and no steroids and anticonvulsants can be enrolled for at least 1 month before entering the study);
- Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in effusion can be enrolled);
- have not recovered adequately from toxicity and/or complications caused by any intervention (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);
- Diagnosis of other malignant tumors within 5 years before the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ that has undergone radical resection, if other malignant tumors or lung cancer are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent metastatic lesions 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 |
|---|---|---|
| DenosumabDenosumab, 120 mg subcutaneous injection, every 21-28 days a cycle, given on the first day, a loading dose is given on d8 of the first cycle, and continued use | Drug | cohort1 |
| tislelizumabTislelizumab, 200 mg intravenous infusion, every 21 days a cycle, given on the first day, and continued use | Drug | cohort1 |
| DocetaxelDocetaxel, 60 mg/m2 intravenous infusion, every 21 days a cycle, given on the first day, and continued use. | Drug | cohort1 |
Primary outcome
progress free survival
Time frame: up to 24 months
Progression-free survival refers to the time from the start of combined treatment to any objectively documented tumor progression or patient death (the last follow-up date for patients lost to follow-up; the end of follow-up date for patients still alive at the end of the study).
4 secondary outcomes
overall survival
Time frame: up to 24 months
objective response rate
Time frame: 12 months
Disease control rate
Time frame: 12 months
Duration of remission
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab, tislelizumab and Docetaxel in people with Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunxia Su (13601899076, susu_mail@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival (time frame: up to 24 months). 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 27 Dec 2024.