Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)

Part of paid clinical trials in Orlando, Florida.

Sponsor
Amgen
Study ID
NCT07778316
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Administered via SC injection or IV infusion

Study Details

The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.

Key Dates

First listed
Aug 21, 2026
Start date
Aug 28, 2026
Status verified
Sep 2026
Primary completion
Sep 24, 2027
Completion
Jul 30, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tarlatamab SC
    Participants will receive Tarlatamab via SC injection
  • Active Comparator: Tarlatamab IV
    Participants will receive Tarlatamab via IV infusion

Primary Outcome Measure

Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab [ Time Frame: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Florida Health Cancer Center at Orlando HealthOrlandoFlorida32806-
Cancer and Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Oncology Hematology West PCOmahaNebraska68130-

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Lung cancer
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OncologyLung oncologyLung disease
By research site
University of Florida Health Cancer Center at Orlando Health· Orlando, FLCancer and Hematology Centers of Western Michigan· Grand Rapids, MIOncology Hematology West PC· Omaha, NE

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