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
330
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
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Etoposide will be administered as an IV infusion.
City of Hope Cancer Center Phoenix
Goodyear, Arizona, United States
RECRUITINGSaint Bernards Medical Center
Jonesboro, Arkansas, United States
RECRUITINGTranslational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Santa Monica, California, United States
RECRUITINGPresbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, California, United States
RECRUITINGColorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGOrlando Health Cancer Institute
Kissimmee, Florida, United States
RECRUITINGCity of Hope Atlanta
Newnan, Georgia, United States
RECRUITINGUniversity of Illinois Chicago
Chicago, Illinois, United States
RECRUITING...and 138 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