Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung CancerDeLLphi-304
Study Details
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).
Protocol Summary
Overall Survival (OS)
Timeframe: Up to approximately 4 years
Progression Free Survival (PFS)
Timeframe: Up to approximately 4 years
Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timeframe: Up to approximately 4 years
Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)
Timeframe: Up to approximately 4 years
Overall Response (OR)
Timeframe: Up to approximately 4 years
Disease Control (DC)
Timeframe: Up to approximately 4 years
Duration of Response (DOR)
Timeframe: Up to approximately 4 years
PFS
Timeframe: 1 year
OS
Timeframe: 1 year, 2 years and 3 years
Incidence of Treatment-Emergent Adverse Events (TEAE)
Timeframe: Up to approximately 4 years
Serum Concentrations of Tarlatamab
Timeframe: Up to 1 year
Number of Participants Who Experience Anti-tarlatamab Antibodies
Timeframe: Up to 1 year
Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)
Timeframe: Up to approximately 4 years
Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)
Timeframe: Up to approximately 4 years
Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS)
Timeframe: Up to approximately 4 years
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Timeframe: Up to approximately 4 years
Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire
Timeframe: Up to approximately 4 years
Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire
Timeframe: Up to approximately 4 years
Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Timeframe: Up to approximately 4 years