First line treatment for extensive-stage small cell lung cancer small cell lung cancer patients (ES-SCLC)
Conditions
Brief summary
Part 1: * Safety and tolerability Dose-limiting toxicities (DLTs), adverse events (AEs) and study intervention discontinuations due to AEs. Part 2: • Progression-free Survival (PFS) per RECIST 1.1 assessed by investigator, Part 2: • Progression-free Survival (PFS) per RECIST 1.1 assessed by investigator
Detailed description
Part 1 (for patients treated at part 2): Objective response per RECIST 1.1 based on investigator, Part 1 (for patients treated at part 2): Duration of response (DOR) per RECIST 1.1 based on investigator, Part 1 (for patients treated at part 2): Overall Survival, Part 2: Objective response per RECIST 1.1 based on investigator, Part 2: DOR per RECIST 1.1 based on investigator, Part 2: Safety and tolerability, Part 2: Overall Survival
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGLenvatinib
Sponsors
Fundacion GECP
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: * Safety and tolerability Dose-limiting toxicities (DLTs), adverse events (AEs) and study intervention discontinuations due to AEs. Part 2: • Progression-free Survival (PFS) per RECIST 1.1 assessed by investigator, Part 2: • Progression-free Survival (PFS) per RECIST 1.1 assessed by investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 (for patients treated at part 2): Objective response per RECIST 1.1 based on investigator, Part 1 (for patients treated at part 2): Duration of response (DOR) per RECIST 1.1 based on investigator, Part 1 (for patients treated at part 2): Overall Survival, Part 2: Objective response per RECIST 1.1 based on investigator, Part 2: DOR per RECIST 1.1 based on investigator, Part 2: Safety and tolerability, Part 2: Overall Survival | — |
Countries
Spain
Outcome results
None listed