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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Tarlatamab will be administered as an intravenous (IV) infusion.
Durvalumab will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
Overall Survival (OS)
Time frame: Up to approximately 3.5 years
Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed)
Time frame: Up to approximately 3.5 years
PFS (Investigator Assessed)
Time frame: Up to approximately 4 years
Objective Response (OR)
Time frame: Up to approximately 4 years
Disease Control
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
PFS Rate
Time frame: 6 months, 1 year, and 2 years
OS Rate
Time frame: 6 months, 1 year, 2 years and 3 years
Time to Progression
Time frame: Up to approximately 4 years
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 4 years
Number of Participants Who Experience Treatment-related Adverse Events
Time frame: Up to approximately 4 years
Number of Participants Who Experience Events of Interest
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Etoposide will be administered as an IV infusion.
Cancer and Blood Specialists of Arizona
Casa Grande, Arizona, United States
City of Hope Cancer Center Phoenix
Goodyear, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Saint Bernards Medical Center
Jonesboro, Arkansas, United States
Providence Saint Jude Medical Center
Fullerton, California, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, United States
University of California Los Angeles
Santa Monica, California, United States
Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, California, United States
Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
New Britain, Connecticut, United States
...and 154 more locations
Time frame: Up to approximately 4 years
Serum Concentrations of Tarlatamab
Time frame: Up to approximately 1 year
Number of Participant Who Develop Anti-Tarlatamab Antibodies
Time frame: Up to 13 months