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)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jul 6, 2020

Status verified

May 2026

Primary completion

May 5, 2027

Completion

Jul 6, 2029

Study Design

Enrollment

870 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo
  Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.
• Experimental: pembrolizumab+chemoradiation→pembrolizumab+olaparib
  Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.
• Active Comparator: chemoradiation→durvalumab
  Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 48 months ]

Locations (33)

Find similar trials in Mobile, AL

Related Studies

• Molecular Analysis of Thoracic Malignancies
  Enrolling By Invitation · Stanford University · Stanford, California
• KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
  PHASE1/PHASE2 · Recruiting · Merck Sharp & Dohme LLC · Gilbert, Arizona
• KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
  Recruiting · Merck Sharp & Dohme LLC · Gilbert, Arizona
• Development and Analysis of a Stool Bank for Cancer Patients
  Recruiting · Persephone Biosciences · Fountain Valley, California