Extensive Stage Small Cell Lung CancerPhase 2DeLLphi-307NCT06502977
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
A Phase 2 study testing Tarlatamab in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 12 sites in China.
Trial summary
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- Tarlatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesChina
- Study dates
- 27 Aug 2024to 10 Dec 2027
- 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
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
- Histologically or cytologically confirmed small cell lung cancer.
- Extensive-stage SCLC participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-[L]1) and at least 1 other prior line of therapy.
- Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
Who cannot join
- Disease Related
- Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC.
- Symptomatic central nervous system (CNS) metastases.
- Diagnosis or evidence of leptomeningeal disease.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- Other Medical Conditions
Show all 33Show fewer
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
- History of solid organ transplantation.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- History of other malignancy within the past 2 years, with certain exceptions
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of study drug.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of study drug.
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study drug.
- HIV, Hepatitis B, and Hepatitis C, with certain exceptions.
- Major surgery within 28 days of first dose study drug. Prior/Concomitant Therapy
- Currently or previously enrolled in a tarlatamab study.
- Prior therapy with any selective inhibitor of the DLL3 pathway.
- Prior anti-cancer therapy within 21 days prior to first dose of study treatment, with certain exceptions.
- Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug, with certain exceptions.
- Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study drug. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for mpox infection) within 3 days prior to first dose of study drug.
- Prior/Concurrent Clinical Study Experience
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Other Exclusions
- Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
- Female participants who are breastfeeding or who plan to breastfeed while on study and for an additional period of time after the last dose of study drug as specified in the study protocol.
- Female participants planning to become pregnant or donate eggs while on study and for an additional period of time after the last dose of study drug as specified in the study protocol.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
- Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
- Male participants unwilling to abstain from donating sperm during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
- Participants has known sensitivity to any of the products or components to be administered during dosing.
- Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
The Second Affiliated Hospital of Army Medical University, People's Liberation Army
Chongqing, Chongqing Municipality, 400037
Army Special Medical Center of Peoples Liberation Army
Chongqing, Chongqing Municipality, 400042
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
Fujian Cancer Hospital
Fuzhou, 350011
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Harbin Meidical University Cancer Hospital
Harbin, Heilongjiang, 150000
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Tarlatamab
- Keywords
- Extensive Stage Small Cell Lung Cancer, Advanced Small Cell Lung Cancer, SCLC, AMG 757, Tarlatamab, IMDELLTRA, Tumor, Programmed Cell Death Protein 1, Programmed Cell Death Ligand 1, PD-1 Protein, PD-L1 Protein, Pharmacokinetics, Malignancy, Cancer, Chinese Participants, China, Platinum, Platinum-based, Neuroendocrine tumor, Bi-specific T-cell engager
- Medical subject headings
- Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Also called AMG 757, IMDELLTRA™
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Tarlatamab | Experimental | Participants will receive tarlatamab as an intravenous (IV) infusions in 28-day cycles. Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR).
CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance.
PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Measured: From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off
Secondary outcomes (13)
Duration of Response (DOR) Based on BICR Per RECIST 1.1
DOR was defined as time from the first documentation of OR until the first documentation of disease progression (PD) or death due to any cause, whichever occured first. Only participants who had achieved OR were evaluated for DOR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have reduction in short axis to <10 mm, NOT total disappearance. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.
Measured: Approximately 24 months
Disease Control (DC) Based on BICR Per RECIST 1.1
DC was defined as CR + PR + stable disease (SD). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrate an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.
Measured: Approximately 24 months
Duration of DC Based on BICR Per RECIST 1.1
Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD.
Measured: Approximately 24 months
Progression-free Survival (PFS) Based on BICR Per RECIST 1.1
PFS was defined as the time from first dose of tarlatamab until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.
Measured: Approximately 24 months
ORR Based on Investigator Assessment Per RECIST 1.1
ORR based on investigator assessment was defined as the percentage of participants with BOR of CR plus PR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters.
Measured: Approximately 24 months
DOR Based on Investigator Assessment Per RECIST 1.1
DOR was defined as time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first. Only participants who had achieved OR would be evaluated for DOR. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.
Measured: Approximately 24 months
DC Based on Investigator Assessment Per RECIST 1.1
DC was defined as CR + PR + SD. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.
Measured: Approximately 24 months
Duration of DC Based on Investigator Assessment Per RECIST 1.1
Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD.
Measured: Approximately24 months
PFS Based on Investigator Assessment Per RECIST 1.1
PFS was defined as time from enrollment until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.
Measured: Approximately 24 months
Overall Survival (OS)
OS was defined as time from the first dose of tarlatamab until death from any cause.
Measured: Approximately 24 months
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were defined as AEs starting on or after the first dose of tarlatamab up to the safety follow-up (SFU) visit or 60 days after the last dose of tarlatamab, whichever was later.
Measured: Approximately 24 months
Trough Concentration (Ctrough) of Tarlatamab
Ctrough of tarlatamab was calculated using standard noncompartmental methods.
Measured: Approximately 24 months
Number of Participants With Anti-tarlatamab Antibodies Formation
Number of participants with anti-tarlatamab (binding and neutralizing) antibodies was presented.
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start27 Aug 2024
- Primary completion28 Mar 2025
- Study completion10 Dec 2027 (estimated)
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 Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502977
- Sponsor's protocol ID
- 20230273
- Acronym
- DeLLphi-307
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2024
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)
- ClinicalTrials.gov ID
- NCT06502977
- Acronym / sponsor ID
- DeLLphi-307 / 20230273
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- Extensive Stage Small Cell Lung Cancer, Advanced Small Cell Lung Cancer, SCLC, AMG 757, Tarlatamab, IMDELLTRA, Tumor, Programmed Cell Death Protein 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tarlatamab | Experimental | Drug: TarlatamabParticipants will receive tarlatamab as an intravenous (IV) infusions in 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
- Histologically or cytologically confirmed small cell lung cancer.
- Extensive-stage SCLC participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-[L]1) and at least 1 other prior line of therapy.
- Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug.
Key exclusion criteria (33 listed)
- Disease Related
- Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC.
- Symptomatic central nervous system (CNS) metastases.
- Diagnosis or evidence of leptomeningeal disease.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
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 |
|---|---|---|
| TarlatamabAlso: AMG 757, IMDELLTRA™IV infusion | Drug | Tarlatamab |
Primary outcome
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off
ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
13 secondary outcomes
Duration of Response (DOR) Based on BICR Per RECIST 1.1
Time frame: Approximately 24 months
Disease Control (DC) Based on BICR Per RECIST 1.1
Time frame: Approximately 24 months
Duration of DC Based on BICR Per RECIST 1.1
Time frame: Approximately 24 months
Progression-free Survival (PFS) Based on BICR Per RECIST 1.1
Time frame: Approximately 24 months
ORR Based on Investigator Assessment Per RECIST 1.1
Time frame: Approximately 24 months
DOR Based on Investigator Assessment Per RECIST 1.1
Time frame: Approximately 24 months
DC Based on Investigator Assessment Per RECIST 1.1
Time frame: Approximately 24 months
Duration of DC Based on Investigator Assessment Per RECIST 1.1
Time frame: Approximately24 months
PFS Based on Investigator Assessment Per RECIST 1.1
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 24 months
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 24 months
Trough Concentration (Ctrough) of Tarlatamab
Time frame: Approximately 24 months
Number of Participants With Anti-tarlatamab Antibodies Formation
Time frame: Approximately 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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. This study is not recruiting at the moment.
MD study director
Amgen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarlatamab in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 12 sites 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 8 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Yes. Results are posted in the registry (first posted 15 Apr 2026). 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?
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off). 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 21 Oct 2026.