Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum based First-line Chemotherapy (ES-SCLC)DeLLphi-315
Study Details
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
Protocol Summary
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Timeframe: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
Timeframe: On Cycle 2 Day 15 (each cycle is 28 days)
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Timeframe: Up to approximately 4 years
Progression free survival (PFS) per RECIST v1.1
Timeframe: Up to approximately 4 years
Duration of response (DOR) per RECIST v1.1
Timeframe: Up to approximately 4 years
Disease control (DC) per RECIST v1.1
Timeframe: Up to approximately 4 years
Overall survival (OS)
Timeframe: Up to approximately 4 years
Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Timeframe: Up to approximately 4 years
Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Timeframe: Up to approximately 4 years
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Timeframe: Up to approximately 4 years
Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Timeframe: Up to approximately 4 years
Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Timeframe: Up to approximately 4 years
Number of Participants with Anti-tarlatamab Antibody Formation
Timeframe: Up to approximately 4 years