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Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)
Sponsor: Amgen
Summary
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.
Official title: A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-08-28
Completion Date
2030-07-30
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
Tarlatamab
Administered via SC injection or IV infusion
Locations (9)
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Oncology Hematology West PC
Omaha, Nebraska, United States
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Shanghai Pulmonary Hospital
Shanghai, China
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, Japan
Universitaetsspital Zuerich
Zurich, Switzerland