Tarlatamab History and Updates

119 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 31, 2026.

FDA Approvals

Label Revisions

117

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-08-27Download 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)

2026

Results postedTarlatamab Phase 2 Trial for SCLC Shows 38.7% Objective Response Rate· Apr 15, 2026

2025

FDA approval (supplemental)Tarlatamab: FDA Approves Supplemental Application for Efficacy· Nov 19, 2025
Results postedTarlatamab Phase 1 Trial in Neuroendocrine Prostate Cancer Shows 12% ORR· Sep 12, 2025

Upcoming & expected milestones

Trial startedOct 1, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07788677

Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA

Primary completionOct 18, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT07016230

Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differe

Primary completionDec 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05060016

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT03319940

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Trial startedJan 15, 2027· ClinicalTrials.gov

Phase 2 trial started: NCT07788365

Tarlatamab in Recurrent Gynecological Neuroendocrine Carcinomas: A Phase II Proof-of-concept Study

Trial startedJan 31, 2027· ClinicalTrials.gov

Phase 3 trial started: NCT07637513

Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

Primary completionFeb 1, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Primary completionMar 3, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Primary completionMar 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06830694

Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Sm

Primary completionApr 15, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07016230

Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differe

Primary completionApr 24, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Primary completionJul 5, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06211036

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following P

Primary completionAug 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07111507

A Study of Tarlatamab for People With Prostate Cancer

Primary completionSep 24, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07778316

Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)

Primary completionDec 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05060016

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07423585

Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06816394

Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)

Primary completionMar 3, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06776250

Study of How Safe and Effective Tarlatamab is in Brain Cancers

Primary completionMar 18, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT07037758

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Primary completionApr 24, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06788938

Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms

Primary completionMay 21, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT07531095

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Primary completionAug 28, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT05361395

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cance

Primary completionOct 16, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT06551142

A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07061080

Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab

Primary completionJan 4, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07005128

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive S

Primary completionFeb 1, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06937905

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated

Primary completionFeb 9, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06745323

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

Primary completionFeb 28, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07402343

Tarlatamab for SCLC Brain Metastases

Primary completionApr 30, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06893783

Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients

Primary completionMay 1, 2029· ClinicalTrials.gov

Phase 1 primary completion: NCT07788677

Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA

Primary completionMay 10, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06745323

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

Primary completionOct 31, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07203053

A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

Primary completionOct 31, 2029· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07243470

Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors

Primary completionApr 20, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT06117774

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Primary completionMay 31, 2030· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06814496

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

Primary completionJun 1, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07242547

Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients

Primary completionAug 31, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07788365

Tarlatamab in Recurrent Gynecological Neuroendocrine Carcinomas: A Phase II Proof-of-concept Study

Primary completionJun 23, 2031· ClinicalTrials.gov

Phase 1 primary completion: NCT06898957

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (E

Primary completionNov 30, 2037· ClinicalTrials.gov

Phase 3 primary completion: NCT07637513

Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

Past events

2026

Trial startedAug 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07402343

Tarlatamab for SCLC Brain Metastases

Trial startedAug 31, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07778316

Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)

Trial registeredAug 26, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07788677

Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA

Trial registeredAug 26, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07788365

Tarlatamab in Recurrent Gynecological Neuroendocrine Carcinomas: A Phase II Proof-of-concept Study

Trial registeredAug 21, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07778316

Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)

Trial registeredJun 9, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07637513

Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07402343

Tarlatamab for SCLC Brain Metastases

Trial startedMay 28, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07242547

Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients

Primary completionApr 25, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07328490

Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage

Trial startedApr 25, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07328490

Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage

Trial startedApr 21, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07531095

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Trial startedApr 15, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07203053

A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

Trial registeredApr 15, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07531095

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Results postedApr 15, 2026· ClinicalTrials.gov

Trial results posted: NCT06502977

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Trial startedApr 1, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07423585

Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

Trial registeredFeb 20, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07423585

Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

Trial registeredFeb 11, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07402343

Tarlatamab for SCLC Brain Metastases

Trial startedFeb 6, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT06937905

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated

Trial registeredJan 9, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07328490

Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage

Results postedJan 5, 2026· ClinicalTrials.gov

Trial results posted: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

2025

Trial startedDec 18, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07061080

Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab

Trial registeredNov 24, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07243470

Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors

Trial registeredNov 21, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07242547

Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients

FDA approval (supplemental)Nov 19, 2025· FDA

FDA approved supplemental application for Imdelltra (amg757) (tarlatamab-dlle) — Efficacy (BLA 761344 S-1)

Sponsor: AMGEN INC. Class: Efficacy.

Trial startedNov 4, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07243470

Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors

Trial registeredOct 2, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07203053

A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

Trial startedSep 16, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT07037758

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Results postedSep 12, 2025· ClinicalTrials.gov

Trial results posted: NCT04702737

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Trial startedSep 8, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06814496

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

Trial startedSep 2, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06893783

Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients

Trial startedAug 18, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06776250

Study of How Safe and Effective Tarlatamab is in Brain Cancers

Trial startedAug 18, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07005128

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive S

Trial registeredAug 8, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07111507

A Study of Tarlatamab for People With Prostate Cancer

Trial startedJul 31, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07111507

A Study of Tarlatamab for People With Prostate Cancer

Trial registeredJul 11, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07061080

Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab

Trial startedJul 2, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07016230

Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differe

Trial registeredJun 25, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07037758

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Trial registeredJun 11, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07016230

Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differe

Trial registeredJun 5, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07005128

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive S

Trial startedMay 16, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06898957

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (E

Trial startedMay 15, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06816394

Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)

Trial startedMay 13, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06830694

Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Sm

Trial registeredApr 22, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06937905

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated

Primary completionMar 28, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06502977

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Trial registeredMar 27, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06898957

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (E

Trial registeredMar 25, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06893783

Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients

Trial startedMar 21, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06788938

Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms

Trial startedFeb 26, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06745323

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

Trial registeredFeb 17, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06830694

Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Sm

Trial registeredFeb 10, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06816394

Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)

Trial registeredFeb 7, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06814496

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

Primary completionJan 29, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Trial registeredJan 23, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06788938

Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms

Trial registeredJan 15, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06776250

Study of How Safe and Effective Tarlatamab is in Brain Cancers

2024

Trial registeredDec 20, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06745323

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

Results postedOct 15, 2024· ClinicalTrials.gov

Trial results posted: NCT04885998

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Trial startedOct 7, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Trial registeredSep 19, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Trial startedAug 27, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06502977

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Primary completionJul 22, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT04702737

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Trial registeredJul 16, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06502977

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Trial startedJun 5, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06211036

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following P

FDA approvalMay 16, 2024· FDA

FDA approved Imdelltra (amg757) (tarlatamab-dlle) (BLA 761344)

Sponsor: AMGEN INC. Class: Type 1 - New Molecular Entity.

Trial startedFeb 20, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06117774

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Trial registeredJan 18, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06211036

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following P

2023

Trial registeredNov 7, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06117774

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Trial registeredOct 3, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06064500

Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Primary completionJul 12, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT04885998

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Trial startedMay 31, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Trial registeredFeb 23, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

2022

Trial startedAug 24, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05361395

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cance

Trial registeredMay 4, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05361395

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cance

2021

Trial startedDec 1, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05060016

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

Trial registeredSep 28, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05060016

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

Trial startedSep 27, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04885998

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Trial startedJun 10, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04702737

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Trial registeredMay 13, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04885998

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Trial registeredJan 11, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04702737

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

2017

Trial startedDec 26, 2017· ClinicalTrials.gov

Phase 1 trial started: NCT03319940

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Trial registeredOct 24, 2017· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03319940

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.