Small Cell Lung CancerPhase 1NCT04885998
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
A Phase 1 study testing Tarlatamab and AMG 404 in people with Small Cell Lung Cancer, run by Amgen at 17 sites in 6 countries.
Trial summary
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Tarlatamab and AMG 404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 27 Sep 2021to 11 Sep 2024
- Phase
- Phase 1
- 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/assent prior to initiation of any study specific activities/procedures
- Age greater than or equal to 18 years old at the same time of signing the informed consent
- Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) 0 to 1
- Participants with treated brain metastases are eligible provided they meet defined criteria
- Adequate organ function as defined in protocol
Who cannot join
- History of other malignancy within the past 2 years with exceptions
- Major surgery within 28 days of first dose of tarlatamab
- Untreated or symptomatic brain metastases and leptomeningeal disease
- Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab
- Exceptions:
- Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1.
Show all 15Show fewer
- Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab
- Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
- Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
- History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
- Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
- History of solid organ transplantation
- History of hypophysitis or pituitary dysfunction
- 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. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United States7 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University, Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Kentucky
Lexington, Kentucky, 40536
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, 27157
Austria2 sites
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Belgium2 sites
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
Japan2 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Singapore2 sites
National University Hospital
Singapore, 119074
National Cancer Centre Singapore
Singapore, 169610
Taiwan2 sites
Chung Shan Medical University Hospital
Taichung, 40201
Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Tarlatamab, AMG 404
- Keywords
- Small Cell Lung Cancer, SCLC, Lung Cancer, AMG 757, AMG 404, Tarlatamab
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Also called AMG 757
Tarlatamab will be administered as an intravenous (IV) infusion.
AMG 404Drug
AMG 404 will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Exploration | Experimental | The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD). Receives: Drug: Tarlatamab; Drug: AMG 404 |
| Phase 2: Dose Expansion | Experimental | Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study. Receives: Drug: Tarlatamab; Drug: AMG 404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events v4.0:
- Grade 3 adverse event (AE) except for fatigue lasting < 7 days, Grade 3 nonfebrile neutropenia that improved to ≤ Grade 1 within 3 weeks, endocrinopathies if managed with replacement therapy, Grade 3 nausea/vomiting or diarrhea for < 72 hours, Grade 3 amylase or lipase values not associated with pancreatitis, Grade 3 hematologic laboratory abnormalities not clinically relevant, or Grade 3 electrolyte abnormality up to 72 hours.
- Grade 4 AE except for Grade 4 nonfebrile neutropenia lasting ≤ 7 days, Grade 4 electrolyte abnormality lasting up to 72 hours, Grade 4 amylase or lipase values not associated with pancreatitis, or Grade 4 hematologic laboratory abnormalities no clinically relevant.
- Grade 5 AE
- Recurrent Grade ≥ 2 pneumonitis
- Any other toxicity requiring permanent discontinuation of AMG 404.
Measured: First dose of tarlatamab up to 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (IP; tarlatamab) up to 65 days after the last dose of tarlatamab or AMG 404 or the end of study (EOS), whichever was earlier. A TEAE for the EP was an AE that occurred after the 65th day after the last dose of tarlatamab or AMG 404 up to 145 days after the last dose of tarlatamab or AMG 404 or end of study, whichever was later. A treatment-related AE was any TEAE where there was a reasonable possibility that the TEAE could have been caused by tarlatamab or AMG 404. Any clinically significant changes in vital signs, physical examinations, electrocardiograms, and clinical laboratory tests were included as TEAEs.
Measured: Any TEAEs: From first IP dose up to last dose + 65 days or EOS, median duration was 4.2 months; TEAEs for EP: From last dose + 65 days up to snapshot date (15 November 2024), death, or last dose + 145 days or EOS, median duration was 2.6 months
Secondary outcomes (8)
Objective Response Rate Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.
CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to < 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR. Exact 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method.
Measured: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months
Duration of Response Per Modified RECIST v1.1
The duration of response was defined as the time from first evidence of CR or PR to progressive disease (PD) or death due to any cause, whichever occurred first, estimated via Kaplan-Meier methods.
CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to < 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR. PD: radiologic detection of ≥ 20% increase in tumor burden relative to nadir and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method.
Measured: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months
Disease Control Rate Per Modified RECIST v1.1
The disease control rate was defined as the percentage of participants with a best overall response of a confirmed response (CR/PR) or stable disease (SD) while on the study as defined by modified RECIST v1.1.
CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to < 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR SD: Index lesions not meeting the criteria for CR, PR, or PD or the persistence of one or more non-index lesions. Exact 95% CIs were calculated using the Clopper-Pearson method.
Measured: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months
Progression-free Survival Per Modified RECIST v1.1
Progression-free survival was defined as the interval from the earlier date of the first dose of IP to the earlier of PD per modified RECIST v1.1 or death due to any cause, estimated via Kaplan-Meier methods.
PD: radiologic detection of ≥ 20% increase in tumor burden to nadir and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions.
Confirmation scans were required within 4 weeks of the first documented response of CR or PR, and 4-6 weeks for PD. 95% CIs were calculated using the Brookmeyer and Crowley method.
Measured: From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months
Overall Survival
Overall survival was defined as the interval from the earlier date of the first dose of IP to the event of death due to any cause, estimated via Kaplan-Meier methods. Participants who were still alive were censored at the date last known to be alive. If the date last known to be alive was after the data cutoff date, the participant was censored at the analysis trigger date. 95% CIs were calculated using the Brookmeyer and Crowley method.
Measured: From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404
Cmax was obtained using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified.
Measured: Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose)
Trough Concentration (Ctrough) of Tarlatamab in Combination With AMG 404
Ctrough was obtained at the end of a dosing interval or just before the administration of the next planned dose using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified.
Measured: Cycle 2 Day 15 (pre-dose)
Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404
AUC0-336 was defined as the actual body exposure to the drug over time following administration of a dose, calculated from time zero to 336 hours post-dose using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified.
Measured: Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start27 Sep 2021
- Primary completion12 Jul 2023
- Study completion11 Sep 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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT04885998
- Sponsor's protocol ID
- 20200439
- Other IDs
- 2020-005957-26
- Status last verified
- Aug 2025
- First submitted
- 10 May 2021
- Last updated
- 29 Sep 2025
- 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT04885998
- Acronym / sponsor ID
- 20200439
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, SCLC, Lung Cancer, AMG 757, AMG 404, Tarlatamab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Exploration | Experimental | Drug: Tarlatamab, Drug: AMG 404The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD). |
| Phase 2: Dose Expansion | Experimental | Drug: Tarlatamab, Drug: AMG 404Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
- Age greater than or equal to 18 years old at the same time of signing the informed consent
- Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) 0 to 1
- Participants with treated brain metastases are eligible provided they meet defined criteria
Key exclusion criteria (15 listed)
- History of other malignancy within the past 2 years with exceptions
- Major surgery within 28 days of first dose of tarlatamab
- Untreated or symptomatic brain metastases and leptomeningeal disease
- Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab
- Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1.
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 757Tarlatamab will be administered as an intravenous (IV) infusion. | Drug | Phase 1: Dose Exploration, Phase 2: Dose Expansion |
| AMG 404AMG 404 will be administered as an intravenous (IV) infusion. | Drug | Phase 1: Dose Exploration, Phase 2: Dose Expansion |
Primary outcome
Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
Time frame: First dose of tarlatamab up to 28 days
A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events v4.0: * Grade 3 adverse event (AE) except for fatigue lasting < 7 days, Grade 3 nonfebrile neutropenia that improved to ≤ Grade 1 within 3 weeks, endocrinopathies if managed with replacement therapy, Grade 3 nausea/vomiting or diarrhea for < 72 hours, Grade 3 amylase or lipase values not associated with pancreatitis, Grade 3 hematologic laboratory abnormalities not clinically relevant, or Grade 3 electrolyte abnormality up to 72 hours. * Grade 4 AE except for Grade 4 nonfebrile neutropenia lasting ≤ 7 days, Grade 4 electrolyte abnormality lasting up to 72 hours, Grade 4 amylase or lipase values not associated with pancreatitis, or Grade 4 hematologic laboratory abnormalities no clinically relevant. * Grade 5 AE * Recurrent Grade ≥ 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Any TEAEs: From first IP dose up to last dose + 65 days or EOS, median duration was 4.2 months; TEAEs for EP: From last dose + 65 days up to snapshot date (15 November 2024), death, or last dose + 145 days or EOS, median duration was 2.6 months
An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (IP; tarlatamab) up to 65 days after the last dose of tarlatamab or AMG 404 or the end of study (EOS), whichever was earlier. A TEAE for the EP was an AE that occurred after the 65th day after the last dose of tarlatamab or AMG 404 up to 145 days after the last dose of tarlatamab or AMG 404 or end of study, whichever was later. A treatment-related AE was any TEAE where there was a reasonable possibility that the TEAE could have been caused by tarlatamab or AMG 404. Any clinically significant changes in vital signs, physical examinations, electrocardiograms, and clinical laboratory tests were included as TEAEs.
8 secondary outcomes
Objective Response Rate Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months
Duration of Response Per Modified RECIST v1.1
Time frame: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months
Disease Control Rate Per Modified RECIST v1.1
Time frame: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months
Progression-free Survival Per Modified RECIST v1.1
Time frame: From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months
Overall Survival
Time frame: From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404
Time frame: Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose)
Trough Concentration (Ctrough) of Tarlatamab in Combination With AMG 404
Time frame: Cycle 2 Day 15 (pre-dose)
Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404
Time frame: Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- 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
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarlatamab and AMG 404 in people with Small Cell Lung Cancer, run by Amgen at 17 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 6 inclusion and 15 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Austria, Belgium, Japan, Singapore 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Oct 2024). 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 Who Experienced Dose-limiting Toxicity (DLT) (time frame: First dose of tarlatamab up to 28 days). The study lists 2 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 29 Sep 2025.