drugset / Trial / NCT05224141

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

NCT05224141

Phase 3 Active not recruiting 460 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Timeline

Start
2022-03-24
Primary completion
2024-06-04
Completion
2027-06-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Vibostolimab Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous