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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

Saint Bernards Medical Center
Jonesboro 4116834, Arkansas 4099753 72401

Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier 5409059, California 5332921 90602

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510

University of Illinois Chicago
Chicago 4887398, Illinois 4896861 60612

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis 4259418, Indiana 4921868 46202

Cancer Center of Kansas, Heritage Plaza Medical Building
Wichita 4281730, Kansas 4273857 67214

Allina Health System dba Allina Health Cancer Institute
Minneapolis 5037649, Minnesota 5037779 55407

Kaiser Permanente Medical Center
Portland 5746545, Oregon 5744337 97227

Baptist Cancer Center
Memphis 4641239, Tennessee 4662168 38120

Swedish Cancer Institute Medical Oncology
Seattle 5809844, Washington 5815135 98104

West Virginia University Health Sciences Center
Morgantown 4815352, West Virginia 4826850 26506

More Details

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.