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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tarlatamab + Durvalumab + Carboplatin + Etoposide 		Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
  • Drug: Tarlatamab
    Tarlatamab will be administered as an intravenous (IV) infusion.
    Other names:
    • AMG 757
    • Imdelltra
  • Drug: Durvalumab
    Durvalumab will be administered as an IV infusion.
  • Drug: Carboplatin
    Carboplatin will be administered as an IV infusion.
  • Drug: Etoposide
    Etoposide will be administered as an IV infusion.
Active Comparator
Durvalumab + Carboplatin + Etoposide 		Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
  • Drug: Tarlatamab
    Tarlatamab will be administered as an intravenous (IV) infusion.
    Other names:
    • AMG 757
    • Imdelltra
  • Drug: Durvalumab
    Durvalumab will be administered as an IV infusion.
  • Drug: Carboplatin
    Carboplatin will be administered as an IV infusion.
  • Drug: Etoposide
    Etoposide will be administered as an IV infusion.

Recruiting Locations

City of Hope Cancer Center Phoenix
Goodyear, Arizona 85338

Saint Bernards Medical Center
Jonesboro, Arkansas 72401

Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California 90095

University of California Los Angeles
Santa Monica, California 90404

Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, California 90602

Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado 81505

Yale New Haven Hospital
New Haven, Connecticut 06510

Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida 32256

Orlando Health Cancer Institute
Kissimmee, Florida 34744

City of Hope Atlanta
Newnan, Georgia 30265

University of Illinois Chicago
Chicago, Illinois 60612

Cancer Care Specialists of Illinois
Decatur, Illinois 62526

City of Hope Chicago
Rockford, Illinois 61108

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202

Hematology Oncology of Indiana
Indianapolis, Indiana 46260

Cancer Center of Kansas, Heritage Plaza Medical Building
Wichita, Kansas 67214

New England Cancer Specialists
Westbrook, Maine 04092

Dana Farber Cancer Institute
Boston, Massachusetts 02215

Minnesota Oncology Hematology PA
Edina, Minnesota 55435

Allina Health System dba Allina Health Cancer Institute
Minneapolis, Minnesota 55407

Mayo Clinic
Rochester, Minnesota 55905

Cancer Partners of Nebraska
Lincoln, Nebraska 68516

Nebraska Cancer Specialists
Omaha, Nebraska 68130

New York Oncology Hematology PC
Albany, New York 12206

New York Cancer and Blood Specialists
Shirley, New York 11967

Oncology Hematology Care, Inc
Cincinnati, Ohio 45242

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon 97401

Kaiser Permanente Medical Center
Portland, Oregon 97227

Baptist Cancer Center
Memphis, Tennessee 38120

United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee 37203

Texas Oncology
Dallas, Texas 75246

Oncology Consultants
Houston, Texas 77030

US Oncology Research Investigational Products Center
Irving, Texas 75063

Texas Oncology Northeast Texas
Tyler, Texas 75702

Virginia Cancer Specialists PC
Fairfax, Virginia 22031

Virginia Oncology Associates
Norfolk, Virginia 23502

Swedish Cancer Institute Medical Oncology
Seattle, Washington 98104

Northwest Medical Specialties, PLLC
Tacoma, Washington 98405

West Virginia University Health Sciences Center
Morgantown, West Virginia 26506

More Details

NCT ID
NCT07005128
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center