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)

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 672 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab 200 mg	Pembrolizumab 200 mg Q3W
BIOLOGICAL	Pembrolizumab 400 mg	Pembrolizumab 400 mg Q6W
DRUG	Pembrolizumab placebo (saline)	Pembrolizumab placebo (saline) Q3W
DRUG	Pembrolizumab placebo (saline)	Pembrolizumab placebo (saline) Q6W
DRUG	Olaparib 300 mg BID	Olaparib 300 mg twice daily (BID)
DRUG	Olaparib matching placebo	Olaparib matching placebo BID
DRUG	Etoposide 100 mg/m^2	Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3
DRUG	Platinum, investigator's choice	Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle
RADIATION	Standard Thoracic Radiotherapy	Standard Thoracic Radiotherapy
RADIATION	Prophylactic Cranial Irradiation (PCI)	PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Timeline

• Start date: 2020-12-08
• Primary completion: 2027-10-28
• Completion: 2027-10-28
• First posted: 2020-11-10
• Last updated: 2025-07-02

Locations

187 sites across 25 countries: United States, Australia, Belgium, Bulgaria, Canada, China, Estonia, France, Greece, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study