Recruiting
Phase 3

Tarlatamab & Durvalumab

Sponsor:

Amgen

Code:

NCT07005128

Conditions

Small-cell Lung Cancer

Extensive Stage Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tarlatamab

Durvalumab

Carboplatin

Etoposide

Study Details

Brief 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).

Conditions

Small-cell Lung Cancer

Extensive Stage Small-cell Lung Cancer

Study ID

NCT07005128

Start date

Aug 18, 2025

Status verified date

Jul, 2026

Completion date

Jul 15, 2029

Anticipated

Primary completion date

Jan 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tarlatamab + Durvalumab + Carboplatin + Etoposide

Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

active comparator: Durvalumab + Carboplatin + Etoposide

Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.

Interventions

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.

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: Up to approximately 3.5 years ]
  • Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) [ Time Frame: Up to approximately 3.5 years ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Cancer and Blood Specialists of Arizona

Recruiting

Casa Grande, Arizona, United States, 85222

City of Hope Cancer Center Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

Genesis Cancer Center

Recruiting

Hot Springs, Arkansas, United States, 71913

Saint Bernards Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Providence Saint Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

Translational Research in Oncology US Inc, Trio Central Pharmacy

Recruiting

Los Angeles, California, United States, 90095

University of California Los Angeles

Recruiting

Santa Monica, California, United States, 90404

Presbyterian Intercommunity Hospital Health Whitter Hospital

Recruiting

Whittier, California, United States, 90602

Colorado West Healthcare System dba Grand Valley Oncology

Recruiting

Grand Junction, Colorado, United States, 81505

Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

Recruiting

New Britain, Connecticut, United States, 06053

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Eastern Connecticut Hematology and Oncology Associates

Recruiting

Norwich, Connecticut, United States, 06360

Florida Oncology and Hematology

Recruiting

Fort Myers, Florida, United States, 33912

Cancer Specialists of North Florida - Southpoint

Recruiting

Jacksonville, Florida, United States, 32256

Orlando Health Cancer Institute

Recruiting

Kissimmee, Florida, United States, 34744

Central Georgia Cancer Care PC

Recruiting

Macon, Georgia, United States, 31210

City of Hope Atlanta

Recruiting

Newnan, Georgia, United States, 30265

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Cancer Care Specialists of Illinois

Recruiting

Decatur, Illinois, United States, 62526

Midwestern Regional Medical Center dba City of Hope Chicago

Recruiting

Rockford, Illinois, United States, 61108

Indiana University Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Hematology Oncology of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

Cancer Center of Kansas, Heritage Plaza Medical Building

Recruiting

Wichita, Kansas, United States, 67214

New England Cancer Specialists

Recruiting

Westbrook, Maine, United States, 04092

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Minnesota Oncology Hematology PA

Recruiting

Edina, Minnesota, United States, 55435

Allina Health System dba Allina Health Cancer Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Hattiesburg Clinic Hematology/Oncology

Recruiting

Hattiesburg, Mississippi, United States, 39401

Cancer Partners of Nebraska

Recruiting

Lincoln, Nebraska, United States, 68516

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

New York Oncology Hematology PC

Recruiting

Albany, New York, United States, 12206

Hematology Oncology Association of Central New York

Recruiting

East Syracuse, New York, United States, 13057

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Oncology Hematology Care, Inc

Recruiting

Cincinnati, Ohio, United States, 45242

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Willamette Valley Cancer Institute and Research Center - Eugene

Recruiting

Eugene, Oregon, United States, 97401

Kaiser Permanente Medical Center

Recruiting

Portland, Oregon, United States, 97227

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

United States Oncology Regulatory Affairs Corporate Office

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Dallas Fort Worth

Recruiting

Dallas, Texas, United States, 75246

Oncology Consultants

Recruiting

Houston, Texas, United States, 77030

US Oncology Research Investigational Products Center

Recruiting

Irving, Texas, United States, 75063

University of Texas Health Science Center at Tyler

Recruiting

Tyler, Texas, United States, 75701

Texas Oncology Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Virginia Cancer Specialists PC

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Swedish Cancer Institute Medical Oncology

Recruiting

Seattle, Washington, United States, 98104

Northwest Medical Specialties, PLLC

Recruiting

Tacoma, Washington, United States, 98405

West Virginia University Health Sciences Center

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

Amgen

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-07-16.