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)
Public ClinicalTrials.gov record NCT04380636. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04380636
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 870 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Olaparib Drug
- Placebo for olaparib Drug
- Etoposide Drug
- Carboplatin Drug
- Cisplatin Drug
- Paclitaxel Drug
- Pemetrexed Drug
- Thoracic Radiotherapy Radiation
- Durvalumab Drug
Biological · Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 5, 2020
- Primary completion
- May 4, 2027
- Completion
- Jul 5, 2029
- Last update posted
- May 14, 2026
2020 – 2029
United States locations
- U.S. sites
- 33
- U.S. states
- 17
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 0003) | Mobile | Alabama | 36604 | — |
| St. Bernards Medical Center ( Site 0089) | Jonesboro | Arkansas | 72401 | — |
| St Joseph Heritage Healthcare-Oncology ( Site 0088) | Fullerton | California | 92835 | — |
| Long Beach Memorial Medical Center ( Site 0006) | Long Beach | California | 90806 | — |
| UCLA Hematology/Oncology - Santa Monica ( Site 0013) | Los Angeles | California | 90404 | — |
| St. Joseph Heritage Healthcare Local Lab ( Site 0011) | Santa Rosa | California | 95403 | — |
| Torrance Memorial Physician Network / Cancer Center ( Site 0093) | Torrance | California | 90505 | — |
| Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095) | Hollywood | Florida | 33021 | — |
| Miami VA Healthcare System ( Site 0024) | Miami | Florida | 33125 | — |
| Mid Florida Hematology and Oncology Center ( Site 0022) | Orange City | Florida | 32763 | — |
| Orlando Health, UF Health Cancer Center Inc ( Site 0092) | Orlando | Florida | 32806 | — |
| Fort Wayne Medical Oncology and Hematology ( Site 0094) | Fort Wayne | Indiana | 46804 | — |
| Parkview Research Center ( Site 0032) | Fort Wayne | Indiana | 46845 | — |
| Franciscan Health Lafayette East ( Site 0031) | Lafayette | Indiana | 47905 | — |
| University of Kentucky ( Site 0096) | Lexington | Kentucky | 40536 | — |
| Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035) | Louisville | Kentucky | 40241 | — |
| Pikeville Medical Center ( Site 0036) | Pikeville | Kentucky | 41501 | — |
| Massachusetts General Hospital ( Site 0038) | Boston | Massachusetts | 02114 | — |
| Henry Ford Hospital ( Site 0045) | Detroit | Michigan | 48202 | — |
| VA St. Louis Health Care System ( Site 0047) | St Louis | Missouri | 63106 | — |
| Washington University Siteman Cancer Center ( Site 0046) | St Louis | Missouri | 63110 | — |
| CHI Health St. Francis ( Site 0053) | Grand Island | Nebraska | 68803 | — |
| Rutgers Cancer Institute of New Jersey ( Site 0054) | New Brunswick | New Jersey | 08901 | — |
| Valley Health Systems - Ridgewood Campus ( Site 0056) | Paramus | New Jersey | 07652 | — |
| Montefiore Einstein Center ( Site 0083) | The Bronx | New York | 10467 | — |
| Novant Health Presbyterian ( Site 0081) | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center ( Site 0050) | Durham | North Carolina | 27710 | — |
| Piedmont Hematology-Oncology Associates ( Site 0080) | Winston-Salem | North Carolina | 27103 | — |
| The Lindner Center for Research and Education at The Christ Hospital ( Site 0060) | Cincinnati | Ohio | 45219 | — |
| Fox Chase Cancer Center ( Site 0063) | Philadelphia | Pennsylvania | 19111 | — |
| Sanford Cancer Center Oncology Clinic ( Site 0066) | Sioux Falls | South Dakota | 57104 | — |
| Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075) | Seattle | Washington | 98108 | — |
| Cancer Care Northwest ( Site 0074) | Spokane Valley | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 172 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04380636, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 14, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04380636 live on ClinicalTrials.gov.