A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
Recruiting now · Phase 3
Conditions studied: Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer
In brief
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).
Key facts
- Study ID
- NCT07005128
- Run by
- Amgen
- People needed
- 330
- Starts
- 2025-08-18
- Expected to finish
- 2029-07-15
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- City of Hope Cancer Center Phoenix — Goodyear, Arizona, United States (enrolling)
- Genesis Cancer Center — Hot Springs, Arkansas, United States (enrolling)
- Saint Bernards Medical Center — Jonesboro, Arkansas, United States (enrolling)
- Providence Saint Jude Medical Center — Fullerton, California, United States (enrolling)
- Translational Research in Oncology US Inc, Trio Central Pharmacy — Los Angeles, California, United States (enrolling)
- University of California Los Angeles — Santa Monica, California, United States (enrolling)
- Presbyterian Intercommunity Hospital Health Whitter Hospital — Whittier, California, United States (enrolling)
- Colorado West Healthcare System dba Grand Valley Oncology — Grand Junction, Colorado, United States (enrolling)
- Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut — New Britain, Connecticut, United States (enrolling)
- Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States (enrolling)
- Florida Oncology and Hematology — Fort Myers, Florida, United States (enrolling)
- Cancer Specialists of North Florida - Southpoint — Jacksonville, Florida, United States (enrolling)
- Orlando Health Cancer Institute — Kissimmee, Florida, United States (enrolling)
- Central Georgia Cancer Care PC — Macon, Georgia, United States (enrolling)
- City of Hope Atlanta — Newnan, Georgia, United States (enrolling)
- University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
- Cancer Care Specialists of Illinois — Decatur, Illinois, United States (enrolling)
- Midwestern Regional Medical Center dba City of Hope Chicago — Rockford, Illinois, United States (enrolling)
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
- Hematology Oncology of Indiana — Indianapolis, Indiana, United States (enrolling)
- Cancer Center of Kansas, Heritage Plaza Medical Building — Wichita, Kansas, United States (enrolling)
- New England Cancer Specialists — Westbrook, Maine, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Cancer and Blood Specialists of Arizona — Casa Grande, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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