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)
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)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (31 items).
Location: University of South Alabama, Mitchell Cancer Institute ( Site 0003) — Mobile, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has small cell lung cancer or a mixed tumor with presence of small cell elements
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- Has had documented weight loss \>10% (from baseline) in the preceding 3 months
- Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
- Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
- Has had major surgery \<4 weeks prior to the first dose of study treatment (except for placement of vascular access)
- Is expected to require any other form of antineoplastic therapy, while on study
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
- Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \[GCSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
- Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (205 Sites)
Showing the first 25 of 205 sites.
- University of South Alabama, Mitchell Cancer Institute ( Site 0003) — Mobile, Alabama
- St. Bernards Medical Center ( Site 0089) — Jonesboro, Arkansas
- St Joseph Heritage Healthcare-Oncology ( Site 0088) — Fullerton, California
- Long Beach Memorial Medical Center ( Site 0006) — Long Beach, California
- UCLA Hematology/Oncology - Santa Monica ( Site 0013) — Los Angeles, California
- St. Joseph Heritage Healthcare Local Lab ( Site 0011) — Santa Rosa, California
- Torrance Memorial Physician Network / Cancer Center ( Site 0093) — Torrance, California
- Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095) — Hollywood, Florida
- Miami VA Healthcare System ( Site 0024) — Miami, Florida
- Mid Florida Hematology and Oncology Center ( Site 0022) — Orange City, Florida
- Orlando Health, UF Health Cancer Center Inc ( Site 0092) — Orlando, Florida
- Fort Wayne Medical Oncology and Hematology ( Site 0094) — Fort Wayne, Indiana
- Parkview Research Center ( Site 0032) — Fort Wayne, Indiana
- Franciscan Health Lafayette East ( Site 0031) — Lafayette, Indiana
- University of Kentucky ( Site 0096) — Lexington, Kentucky
- Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035) — Louisville, Kentucky
- Pikeville Medical Center ( Site 0036) — Pikeville, Kentucky
- Massachusetts General Hospital ( Site 0038) — Boston, Massachusetts
- Henry Ford Hospital ( Site 0045) — Detroit, Michigan
- VA St. Louis Health Care System ( Site 0047) — St Louis, Missouri
- Washington University Siteman Cancer Center ( Site 0046) — St Louis, Missouri
- CHI Health St. Francis ( Site 0053) — Grand Island, Nebraska
- Rutgers Cancer Institute of New Jersey ( Site 0054) — New Brunswick, New Jersey
- Valley Health Systems - Ridgewood Campus ( Site 0056) — Paramus, New Jersey
- Montefiore Einstein Center ( Site 0083) — The Bronx, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.