A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
Amgen
Summary
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * Measurable disease as defined per RECIST 1.1. * Suitable to receive carboplatin, etoposide a…
Interventions
- DrugTarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
- DrugDurvalumab
Durvalumab will be administered as an IV infusion.
- DrugCarboplatin
Carboplatin will be administered as an IV infusion.
- DrugEtoposide
Etoposide will be administered as an IV infusion.
Locations (153)
- City of Hope Cancer Center PhoenixGoodyear, Arizona
- Saint Bernards Medical CenterJonesboro, Arkansas
- Translational Research in Oncology US Inc, Trio Central PharmacyLos Angeles, California
- University of California Los AngelesSanta Monica, California
- Presbyterian Intercommunity Hospital Health Whitter HospitalWhittier, California
- Colorado West Healthcare System dba Grand Valley OncologyGrand Junction, Colorado