Study Comparing Tarlatamab and Durvalumab versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and DurvalumabDeLLphi-305
Study Details
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
Protocol Summary
OS
Timeframe: Up to approximately 3 years
Progression Free Survival (PFS)
Timeframe: Up to approximately 3 years
Overall Response (OR)
Timeframe: Up to approximately 3 years
Disease Control (DC) Rate
Timeframe: Up to approximately 3 years
Duration of Response (DoR)
Timeframe: Up to approximately 3 years
PFS at 6 Months
Timeframe: 6 months
PFS at 1 Year
Timeframe: 1 year
PFS at 2 Years
Timeframe: 2 years
OS at 6 Months
Timeframe: 6 months
OS at 1 Year
Timeframe: 1 year
OS at 2 Years
Timeframe: 2 years
OS at 3 Years
Timeframe: 3 years
Time to Progression (TTP)
Timeframe: Up to approximately 3 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 9 months
Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Timeframe: Up to approximately 3 years
Number of Participants with Serious TEAEs
Timeframe: Up to approximately 3 years
Number of Participants with TEAEs Leading to Discontinuation of Treatment
Timeframe: Up to approximately 3 years
Number of Participants with Fatal TEAEs
Timeframe: Up to approximately 3 years
Number of Participants with Treatment-related Adverse Events (AEs)
Timeframe: Up to approximately 9 months
Number of Participants with Adverse Events of Interest (EOI)
Timeframe: Up to approximately 9 months
Serum Concentrations of Tarlatamab
Timeframe: Day 1 up to approximately 6 months
Number of Participants with Antitarlatamab Antibody Formation
Timeframe: Up to approximately 9 months
Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Timeframe: Up to approximately 9 months
Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13
Timeframe: Up to 12 months
Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13
Timeframe: Up to 12 months
Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13
Timeframe: Up to 12 months
TTD for Global Health Status as Measured by EORTC-QLQ-C30
Timeframe: Up to approximately 9 months
TTD for Quality of Life as Measured by EORTC-QLQ-C30
Timeframe: Up to approximately 9 months