A Phase 1 interventional study of Tarlatamab and Pembrolizumab in Small Cell Lung Carcinoma, sponsored by Amgen. Active, not recruiting at 39 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
Among 18 studies testing AMG 757 in Small Cell Lung Carcinoma — 9 open to participants now, 17 under way, 6 of them phase 3. AMG 757 · Small Cell Lung Carcinoma.
Among the 18 studies testing AMG 757 in Small Cell Lung Carcinoma, this one is the 7th largest by enrollment, is the only one that started in 2017, is one of 4 in phase 1, reaches primary completion later than 5 of the 16 other live ones, and was the 1st registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
Browse Small Cell Lung Carcinoma studies →9 of the 18 studies testing AMG 757 in Small Cell Lung Carcinoma are open now, in 12 countries. Recruiting first, the newest first:
Amgen · Sites in United States, Australia, China and 2 more countries
Maastricht University Medical Center · Sites in Netherlands
Fundación GECP · Sites in Spain
Amgen · Sites in United States, Australia, Belgium and 6 more countries
Asrar Alahmadi · Sites in United States
By country, each count listing its studies:
AMG 757: first FDA approval 2024 (IMDELLTRA), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →
Of the 264 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 67 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 8 · Phase 3 6
First in 2017; this study’s year is marked. 1 started in 2017.
This study's enrollment of 269 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Median enrollment 221 across the 18 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
11 of 18 have an industry lead sponsor. The 8 most frequent:
Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
19 studies in Small Cell Lung Carcinoma by Amgen: 4 open now, 12 under way, 5 of them phase 3. Of 5 finished, 4 (80%) have results posted.
Among the 19 studies in Small Cell Lung Carcinoma by Amgen, this one is the 8th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2017, is one of 7 in phase 1, reaches primary completion later than 3 of the 11 other live ones, and was the 5th registered.
Amgen’s Small Cell Lung Carcinoma studies by the year they started, since 2002.
4 of the studies testing AMG 757 in Small Cell Lung Carcinoma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07778316Phase 3AmgenPhase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) | 2027-09-24 |
| NCT06830694Sehhoon ParkClinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment | 2027-03-31 |
| NCT06598306AmgenSubcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) | 2027-04-24 |
| NCT07803848AIO-Studien-gGmbHStudy to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status | 2027-07-29 |
Among the 18 studies testing AMG 757 in Small Cell Lung Carcinoma, from their registry updates:
Among Amgen’s 19 in Small Cell Lung Carcinoma:
This tab as a report to print or save as PDF → With an account.
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tarlatamab monotherapy
Drug: Tarlatamab
Tarlatamab with Pembrolizumab
Drug: Tarlatamab · Drug: Pembrolizumab
Tarlatamab with additional CRS mitigation strategies
Drug: Tarlatamab · Drug: CRS Mitigation Strategies
Tarlatamab administration with 24-hour monitoring
Drug: Tarlatamab
Tarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only)
Drug: Tarlatamab
Tarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only)
Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
Participants will be treated with one of the CRS mitigation strategies.
Number of participants with dose limiting toxicities (DLT) for all indications
Time frame: 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications
Time frame: 4 years
Number of participants with treatment-related AEs for all indications
Time frame: 4 years
Number of participants with clinically significant changes in vital signs for all indications
Time frame: 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Time frame: 4 years
Number of participants with significant changes in physical examinations for all indications
Time frame: 4 years
Number of participants with significant changes in clinical laboratory tests for all indications
Time frame: 4 years
Maximum observed concentration (Cmax) following intravenous administration for all indications
Time frame: 4 years
Minimum observed concentration (Cmin) following intravenous administration for all indications
Time frame: 4 years
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Time frame: 4 years
Accumulation following multiple dosing for all indications
Time frame: 4 years
Half-life (t1/2) following intravenous administration for all indications
Time frame: 4 years
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Only for parts A, D, E, F, and G
Time frame: 4 years
Duration of Response (DOR) for all indications
Time frame: 4 years
Time to Response (TTR)
Time frame: 4 years
9-month Progression-Free Survival (PFS) for all indications
Time frame: 9 months
9-month Overall Survival (OS) for all indications
Time frame: 9 months
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Started Dec 2017 (actual). Primary completion is estimated for Dec 2027, 120 months after the start.
Of 111 industry-sponsored phase 1 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 63. This study's planned 120 months is above that.
Counting every sponsor, half of 143 studies reached it within 46 months; a quarter within 29 and three quarters within 64.
Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Dec 2027, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AMG 757