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)

NCT04380636 PHASE3 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE3
Status	ACTIVE_NOT_RECRUITING
Enrolment	870
Start date	Mon Jul 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Feb 15 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

• Pembrolizumab
• Olaparib
• Placebo for olaparib
• Etoposide
• Carboplatin
• Cisplatin
• Paclitaxel
• Pemetrexed
• Thoracic Radiotherapy
• Durvalumab

Countries

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