NCT04380636

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 870 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

Conditions

• Lung Neoplasms
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	intravenous (IV) infusion
DRUG	Olaparib	oral tablets
DRUG	Placebo for olaparib	oral tablets
DRUG	Etoposide	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Cisplatin	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Pemetrexed	IV infusion
RADIATION	Thoracic Radiotherapy	external beam radiation
DRUG	Durvalumab	IV infusion

Timeline

• Start date: 2020-07-06
• Primary completion: 2026-07-06
• Completion: 2027-02-15
• First posted: 2020-05-08
• Last updated: 2025-08-17

Locations

205 sites across 26 countries: United States, Argentina, Canada, Chile, China, Czechia, Estonia, France, Germany, Hungary, Italy, Japan, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Romania, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study