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Clinical Trials in the USA / NCT07005128
Active, not recruiting Phase 3

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

NCT07005128 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-08-18
Last updated
2026-09-08

Condition(s) studied

Small-cell Lung CancerExtensive Stage Small-cell Lung Cancer

Investigational drug(s) / intervention(s)

TarlatamabDurvalumabCarboplatinEtoposide

Tarlatamab: Tarlatamab will be administered as an intravenous (IV) infusion.

Durvalumab: Durvalumab will be administered as an IV infusion.

Carboplatin: Carboplatin will be administered as an IV infusion.

Etoposide: Etoposide will be administered as an IV infusion.

Study summary

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * Measurable disease as defined per RECIST 1.1. * Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment. * Minimum life expectancy ≥ 12 weeks. Exclusion Criteria: * Participants can have no history of other malignancy in the last 2 years. * Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. * They will have no history of severe or life-threatening events to immune-mediated therapy. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment. * They will have no active autoimmune or inflammatory disorders. * Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection. * Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis. * History of solid organ transplant. * They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.

Primary outcome measure(s)

Trial sites (164)

FacilityCityRegionStatus
Cancer and Blood Specialists of Arizona Casa Grande Arizona
City of Hope Cancer Center Phoenix Goodyear Arizona
Genesis Cancer Center Hot Springs Arkansas
Saint Bernards Medical Center Jonesboro Arkansas
Providence Saint Jude Medical Center Fullerton California
Translational Research in Oncology US Inc, Trio Central Pharmacy Los Angeles California
University of California Los Angeles Santa Monica California
Presbyterian Intercommunity Hospital Health Whitter Hospital Whittier California
Colorado West Healthcare System dba Grand Valley Oncology Grand Junction Colorado
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut New Britain Connecticut
Yale New Haven Hospital New Haven Connecticut
Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
Florida Oncology and Hematology Fort Myers Florida
Cancer Specialists of North Florida - Southpoint Jacksonville Florida
Orlando Health Cancer Institute Kissimmee Florida
Central Georgia Cancer Care PC Macon Georgia
City of Hope Atlanta Newnan Georgia
University of Illinois Chicago Chicago Illinois
Cancer Care Specialists of Illinois Decatur Illinois
Midwestern Regional Medical Center dba City of Hope Chicago Rockford Illinois
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
Hematology Oncology of Indiana Indianapolis Indiana
Cancer Center of Kansas, Heritage Plaza Medical Building Wichita Kansas
New England Cancer Specialists Westbrook Maine
Dana Farber Cancer Institute Boston Massachusetts
Minnesota Oncology Hematology PA Edina Minnesota
Allina Health System dba Allina Health Cancer Institute Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi
Cancer Partners of Nebraska Lincoln Nebraska
Nebraska Cancer Specialists Omaha Nebraska
New York Oncology Hematology PC Albany New York
Hematology Oncology Association of Central New York East Syracuse New York
New York Cancer and Blood Specialists Shirley New York
Oncology Hematology Care, Inc Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Willamette Valley Cancer Institute and Research Center - Eugene Eugene Oregon
Kaiser Permanente Medical Center Portland Oregon
Baptist Cancer Center Memphis Tennessee
United States Oncology Regulatory Affairs Corporate Office Nashville Tennessee

+ 124 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

More Amgen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07005128 on ClinicalTrials.gov ↗ ← All trials in the USA