drugset / Trial / NCT04624204

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

NCT04624204

Phase 3 Active not recruiting 672 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.

Timeline

Start
2020-12-08
Primary completion
2027-10-28
Completion
2027-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 300 mg
Subject Pembrolizumab Monoclonal antibody 200 mg
Subject Pembrolizumab Monoclonal antibody 400 mg
Background Carboplatin Small molecule 5 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous