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)
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent. * Histologically or cytologically confirmed SCLC with demonstrated progression or relapse. * Participants who progressed or recurred following 1 platinum-based regimen. * Measurable disease as defined per RECIST 1.1 within the 21-day screening period. * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. * Minimum life expectancy of 12 weeks. * A…
Interventions
- DrugTarlatamab
Administered via SC injection or IV infusion
Locations (9)
- University of Florida Health Cancer Center at Orlando HealthOrlando, Florida
- Cancer and Hematology Centers of Western MichiganGrand Rapids, Michigan
- Oncology Hematology West PCOmaha, Nebraska
- Lyell McEwin HospitalElizabeth Vale, South Australia
- Beijing Chaoyang HospitalBeijing, Beijing Municipality
- Beijing Cancer HospitalBeijing, Beijing Municipality