Tarlatamab History and Updates

105 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

2
FDA Approvals
0
Label Revisions
103
Trial Milestones
0
Pivotal Publications
Tarlatamab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications201820192020202120222023202420252026202720282029203020312032203320342035203620372038Trial: NCT07637513 2027-01-31 → 2037-11-30 (primary completion)Trial: NCT07402343 2026-05-31 → 2029-02-28 (primary completion)Trial: NCT07242547 2026-05-28 → 2030-06-01 (primary completion)Trial: NCT07328490 2026-04-25 → 2026-04-25 (primary completion)Trial: NCT07531095 2026-04-21 → 2028-05-21 (primary completion)Trial: NCT07203053 2026-04-15 → 2029-10-31 (primary completion)Trial: NCT07423585 2026-04-01 → 2027-12-31 (primary completion)Trial: NCT06937905 2026-02-06 → 2029-02-01 (primary completion)Trial: NCT07061080 2025-12-18 → 2028-12-31 (primary completion)Trial: NCT07243470 2025-11-04 → 2029-10-31 (primary completion)Trial: NCT07037758 2025-09-16 → 2028-03-18 (primary completion)Trial: NCT06814496 2025-09-08 → 2030-05-31 (primary completion)Trial: NCT06893783 2025-09-02 → 2029-04-30 (primary completion)Trial: NCT06776250 2025-08-18 → 2028-03-03 (primary completion)Trial: NCT07005128 2025-08-18 → 2029-01-04 (primary completion)Trial: NCT07111507 2025-07-31 → 2027-08-31 (primary completion)Trial: NCT07016230 2025-07-02 → 2027-04-15 (primary completion)Trial: NCT06898957 2025-05-16 → 2031-06-23 (primary completion)Trial: NCT06816394 2025-05-15 → 2027-12-31 (primary completion)Trial: NCT06830694 2025-05-13 → 2027-03-31 (primary completion)Trial: NCT06788938 2025-03-21 → 2028-04-24 (primary completion)Trial: NCT06745323 2025-02-26 → 2029-02-09 (primary completion)Trial: NCT06598306 2024-10-07 → 2027-03-03 (primary completion)Trial: NCT06502977 2024-08-27 → 2025-03-28 (primary completion)Trial: NCT06211036 2024-06-05 → 2027-07-05 (primary completion)Trial: NCT06117774 2024-02-20 → 2030-04-20 (primary completion)Trial: NCT05740566 2023-05-31 → 2025-01-29 (primary completion)Trial: NCT05361395 2022-08-24 → 2028-08-28 (primary completion)Trial: NCT05060016 2021-12-01 → 2026-12-30 (primary completion)Trial: NCT04885998 2021-09-27 → 2023-07-12 (primary completion)Trial: NCT04702737 2021-06-10 → 2024-07-22 (primary completion)Trial: NCT03319940 2017-12-26 → 2026-12-31 (primary completion)FDA approval — 2024-05-16 FDA approved Imdelltra (amg757) (tarlatamab-dlle) (BLA 761344) Sponsor: AMGEN INC. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2025-11-19 FDA approved supplemental application for Imdelltra (amg757) (tarlatamab-dlle) — Efficacy (BLA 761344 S-1) Sponsor: AMGEN INC. Class: Efficacy.Results posted — 2024-10-15 Trial results posted: NCT04885998 AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)Results posted — 2025-09-12 Trial results posted: NCT04702737 A Study of AMG 757 in Participants With Neuroendocrine Prostate CancerResults posted — 2026-01-05 Trial results posted: NCT05740566 Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung CancerResults posted — 2026-04-15 Trial results posted: NCT06502977 Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatmenttoday (2026-06-18)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Tarlatamab since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Primary completion· ClinicalTrials.gov
Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Sm
Primary completion· ClinicalTrials.gov
Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differe
Primary completion· ClinicalTrials.gov
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following P
Primary completion· ClinicalTrials.gov
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Primary completion· ClinicalTrials.gov
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Primary completion· ClinicalTrials.gov
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cance
Primary completion· ClinicalTrials.gov
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive S
Primary completion· ClinicalTrials.gov
Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated
Primary completion· ClinicalTrials.gov
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Primary completion· ClinicalTrials.gov
A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
Primary completion· ClinicalTrials.gov
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (E

Past events

2026
Trial started· ClinicalTrials.gov
Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients
Primary completion· ClinicalTrials.gov
Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage
Trial started· ClinicalTrials.gov
Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage
Trial started· ClinicalTrials.gov
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Trial started· ClinicalTrials.gov
A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
Results posted· ClinicalTrials.gov
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Trial started· ClinicalTrials.gov
Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated
Results posted· ClinicalTrials.gov
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
2025
Trial started· ClinicalTrials.gov
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Trial started· ClinicalTrials.gov
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Trial started· ClinicalTrials.gov
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive S
Trial started· ClinicalTrials.gov
Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differe
Trial started· ClinicalTrials.gov
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (E
Trial started· ClinicalTrials.gov
Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)
Trial started· ClinicalTrials.gov
Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Sm
Primary completion· ClinicalTrials.gov
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Trial started· ClinicalTrials.gov
Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms
Trial started· ClinicalTrials.gov
A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC
2024
Trial started· ClinicalTrials.gov
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Trial started· ClinicalTrials.gov
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Trial started· ClinicalTrials.gov
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following P
Trial started· ClinicalTrials.gov
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
2023
Trial started· ClinicalTrials.gov
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
2022
Trial started· ClinicalTrials.gov
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cance
2021
2017
Trial started· ClinicalTrials.gov
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.