Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)DeLLphi-306
Study Details
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
Protocol Summary
PFS as Determined by BICR
Timeframe: Up to approximately 6 years
OS Over the Whole Trial
Timeframe: Up to approximately 6 years
PFS Determined by Investigator Assessment
Timeframe: Up to approximately 6 years
Complete Response (CR) Rate
Timeframe: Up to approximately 6 years
CR + non-CR/non-Progressive Disease (PD) Rate
Timeframe: Up to approximately 6 years
Duration of Complete Response
Timeframe: Up to approximately 6 years
PFS at 6 months, 1 year, 2 years
Timeframe: 6 months, 1 year, 2 years
OS at 6 months, 1 year, 2 years, 3 years
Timeframe: 6 months, 1 year, 2 years, 3 years
Time to Progression (TTP)
Timeframe: Up to approximately 6 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 6 years
Serum Concentration of Tarlatamab
Timeframe: Up to approximately 4 months
Incidence of Anti-tarlatamab Antibody Formation
Timeframe: Up to approximately 1 year