RecruitingInterventionalPhase 3

A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

NCT ID: NCT07005128Sponsor: AmgenLast updated: 2026-06-12

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).

Arms & interventions

DrugTarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
DrugDurvalumab
Durvalumab will be administered as an IV infusion.
DrugCarboplatin
Carboplatin will be administered as an IV infusion.
DrugEtoposide
Etoposide will be administered as an IV infusion.

Outcome measures

Primary

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

Secondary

PFS (Investigator Assessed)
Time frame: Up to approximately 4 years
Objective Response (OR)
Time frame: Up to approximately 4 years
Disease Control
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
PFS Rate
Time frame: 6 months, 1 year, and 2 years
OS Rate
Time frame: 6 months, 1 year, 2 years and 3 years
Time to Progression
Time frame: Up to approximately 4 years
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 4 years
Number of Participants Who Experience Treatment-related Adverse Events
Time frame: Up to approximately 4 years
Number of Participants Who Experience Events of Interest
Time frame: Up to approximately 4 years
Serum Concentrations of Tarlatamab
Time frame: Up to approximately 1 year
Number of Participant Who Develop Anti-Tarlatamab Antibodies
Time frame: Up to 13 months

Eligibility criteria

Sex: AllAge: 18 Years to 99 YearsHealthy 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.

Study locations (44)

Cancer and Blood Specialists of Arizona

Casa Grande, Arizona, 85222

Recruiting

City of Hope Cancer Center Phoenix

Goodyear, Arizona, 85338

Recruiting

Genesis Cancer Center

Hot Springs, Arkansas, 71913

Recruiting

Saint Bernards Medical Center

Jonesboro, Arkansas, 72401

Recruiting

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, 90095

Recruiting

University of California Los Angeles

Santa Monica, California, 90404

Recruiting

Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California, 90602

Recruiting

Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado, 81505

Recruiting

Yale New Haven Hospital

New Haven, Connecticut, 06510

Recruiting

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360

Recruiting

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, 32256

Recruiting

Orlando Health Cancer Institute

Kissimmee, Florida, 34744

Recruiting

City of Hope Atlanta

Newnan, Georgia, 30265

Recruiting

University of Illinois Chicago

Chicago, Illinois, 60612

Recruiting

Cancer Care Specialists of Illinois

Decatur, Illinois, 62526

Recruiting

Midwestern Regional Medical Center dba City of Hope Chicago

Rockford, Illinois, 61108

Recruiting

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

Recruiting

Hematology Oncology of Indiana

Indianapolis, Indiana, 46260

Recruiting

Cancer Center of Kansas, Heritage Plaza Medical Building

Wichita, Kansas, 67214

Recruiting

New England Cancer Specialists

Westbrook, Maine, 04092

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Minnesota Oncology Hematology PA

Edina, Minnesota, 55435

Recruiting

Allina Health System dba Allina Health Cancer Institute

Minneapolis, Minnesota, 55407

Recruiting

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516

Recruiting

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting

New York Oncology Hematology PC

Albany, New York, 12206

Recruiting

New York Cancer and Blood Specialists

Shirley, New York, 11967

Recruiting

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242

Recruiting

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Recruiting

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, 97401

Recruiting

Kaiser Permanente Medical Center

Portland, Oregon, 97227

Recruiting

Baptist Cancer Center

Memphis, Tennessee, 38120

Recruiting

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, 37203

Recruiting

Texas Oncology - Dallas Fort Worth

Dallas, Texas, 75246

Recruiting

Oncology Consultants

Houston, Texas, 77030

Recruiting

US Oncology Research Investigational Products Center

Irving, Texas, 75063

Recruiting

University of Texas Health Science Center at Tyler

Tyler, Texas, 75701

Recruiting

Texas Oncology Northeast Texas

Tyler, Texas, 75702

Recruiting

Virginia Cancer Specialists PC

Fairfax, Virginia, 22031

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting

Swedish Cancer Institute Medical Oncology

Seattle, Washington, 98104

Recruiting

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405

Recruiting

West Virginia University Health Sciences Center

Morgantown, West Virginia, 26506

Recruiting