Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Amgen
Study ID
NCT05740566
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Tarlatamab will be administered as an IV infusion.
  • Lurbinectedin — DRUG
    Lurbinectedin will be administered per local SOC.
  • Topotecan — DRUG
    Topotecan will be administered per local SOC.
  • Amrubicin — DRUG
    Amrubicin will be administered per local SOC.

Study Details

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Key Dates

Start date
May 31, 2023
Status verified
Nov 2025
Primary completion
Jan 29, 2025
Completion
Mar 26, 2028

Study Design

Enrollment
509 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tarlatamab
    Participants will receive tarlatamab as an intravenous (IV) infusion.
  • Active Comparator: Standard of Care
    Participants will receive treatment per local standard of care (SOC).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months ]

Locations (25)

FacilityCityStateZIPSite coordinators
University of South Alabama Mitchell Cancer InstituteMobileAlabama36604-
Alaska Oncology and HematologyAnchorageAlaska99508-
University of Arkansas for Medical SciencesLittle RockArkansas72205-
University of California Los AngelesSanta MonicaCalifornia90404-
Northwestern UniversityChicagoIllinois60611-
University of Illinois ChicagoChicagoIllinois60612-
Indiana UniversityIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
Pikeville Medical CenterPikevilleKentucky41501-
Our Lady of the Lake Cancer InstituteBaton RougeLouisiana70808-
Trinity Health Saint Joseph Mercy Ann ArborAnn ArborMichigan48106-
University of Minnesota Cancer CenterMinneapolisMinnesota55455-
University of Missouri Health CareColumbiaMissouri65212-
Summit Medical Group, Overlook Oncology CenterSummitNew Jersey91010-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
New York University Grossman School of Medicine and New York University Langone HospitalsNew YorkNew York10016-
Perlmutter Cancer Center at New York University Langone Hospital----Long IslandNew YorkNew York10016-
Northport Veterans Affairs Medical CenterNorthportNew York11768-
Sanford Roger Maris Cancer CenterFargoNorth Dakota58102-
Sanford Oncology Clinic and PharmacySioux FallsSouth Dakota57104-
University of Tennessee Medical Center KnoxvilleKnoxvilleTennessee37920-
Baptist Cancer CenterMemphisTennessee38120-
Virginia Commonwealth UniversityRichmondVirginia23298-
Swedish Cancer Institute Medical OncologyEdmondsWashington98026-
The Medical College of WisconsinMilwaukeeWisconsin53226-

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