Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT06117774
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Tarlatamab — DRUG
    Intravenous (IV) infusion
  • Placebo — DRUG
    IV infusion

Study Details

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).

Key Dates

Start date
Feb 20, 2024
Status verified
Apr 2026
Primary completion
Apr 20, 2030
Completion
Apr 20, 2030

Study Design

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

Arms

  • Experimental: Tarlatamab
    Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
  • Placebo Comparator: Placebo
    Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).

Primary Outcome Measure

PFS as Determined by BICR [ Time Frame: Up to approximately 6 years ]

Locations (18)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
University of California Los AngelesSanta MonicaCalifornia90404-
Yale New Haven HospitalNew HavenConnecticut06510-
Boca Raton Clinical Research Global South FloridaPlantationFlorida33322-
University of Louisville James Graham Brown Cancer CenterLouisvilleKentucky40202-
Our Lady of the Lake Cancer InstituteBaton RougeLouisiana70808-
Morristown Medical CenterMorristownNew Jersey07960-
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-
Montefiore Einstein Center for Cancer CareThe BronxNew York10461-
FirstHealth Cancer CenterPinehurstNorth Carolina28374-
Lehigh Valley Health NetworkAllentownPennsylvania18103-
Spokenword Clinical TrialsEastonPennsylvania18045-
Renovatio ClinicalThe WoodlandsTexas77380-
US Oncology Research Investigational Products CenterThe WoodlandsTexas77380-
University of Virginia Health SystemCharlottesvilleVirginia22908-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
West Virginia University Health Sciences CenterMorgantownWest Virginia26506-

Find similar trials in Los Angeles, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Valkyrie Clinical Trials· Los Angeles, CAUniversity of California Los Angeles· Santa Monica, CAYale New Haven Hospital· New Haven, CTBoca Raton Clinical Research Global South Florida· Plantation, FLUniversity of Louisville James Graham Brown Cancer Center· Louisville, KYOur Lady of the Lake Cancer Institute· Baton Rouge, LA

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