Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04380636 · ClinicalTrials.gov registry record · Phase 3
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 Carcinoma, Non-Small Cell Lung and Lung Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 870
- Enrollment target
- 20
- Study locations
NCT04380636: Active Phase 3 study of Carcinoma, Non-Small Cell Lung and Lung Neoplasms, sponsored by Merck Sharp & Dohme.
NCT04380636 is a Phase 3 study of Carcinoma, Non-Small Cell Lung and Lung Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 870 participants, above the 317-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (174% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380636, a Phase 3 study of Carcinoma, Non-Small Cell Lung and Lung Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 870 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Olaparib
- DRUG Etoposide
- DRUG Placebo for olaparib
Study Locations (20)
California
- St Joseph Heritage Healthcare-Oncology ( Site 0088) - Fullerton
- Long Beach Memorial Medical Center ( Site 0006) - Long Beach
- UCLA Hematology/Oncology - Santa Monica ( Site 0013) - Los Angeles
- St. Joseph Heritage Healthcare Local Lab ( Site 0011) - Santa Rosa
- Torrance Memorial Physician Network / Cancer Center ( Site 0093) - Torrance
Florida
- Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095) - Hollywood
- Miami VA Healthcare System ( Site 0024) - Miami
- Mid Florida Hematology and Oncology Center ( Site 0022) - Orange City
- Orlando Health, UF Health Cancer Center Inc ( Site 0092) - Orlando
Indiana
- Fort Wayne Medical Oncology and Hematology ( Site 0094) - Fort Wayne
- Parkview Research Center ( Site 0032) - Fort Wayne
- Franciscan Health Lafayette East ( Site 0031) - Lafayette
Kentucky
- University of Kentucky ( Site 0096) - Lexington
- Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035) - Louisville
- Pikeville Medical Center ( Site 0036) - Pikeville
Alabama
- University of South Alabama, Mitchell Cancer Institute ( Site 0003) - Mobile
Arkansas
- St. Bernards Medical Center ( Site 0089) - Jonesboro
Massachusetts
- Massachusetts General Hospital ( Site 0038) - Boston
Michigan
- Henry Ford Hospital ( Site 0045) - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 3 |
What the registry record for NCT04380636 still lists
NCT04380636 is an interventional study that assigns participants to a tested intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap, above the 317-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (174% higher).
The record links to 2 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04380636 names 20 study sites across 9 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT04380636 about?
NCT04380636 is a clinical study titled "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)". 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) i...
What is the current status of trial NCT04380636?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 870 participants. The study started on 2020-07-06. Estimated completion is 2027-02-15.
What conditions does trial NCT04380636 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Lung Neoplasms.
What interventions are being tested in trial NCT04380636?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Olaparib (DRUG), Etoposide (DRUG), Placebo for olaparib (DRUG).
Who is sponsoring clinical trial NCT04380636?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04380636 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Non-Small Cell Lung
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04380636's enrollment target sits among peer trials
870 10th of 130 higher than 121 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
RECRUITING · Phase 3
-
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
RECRUITING · Phase 3
-
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 3
-
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
RECRUITING · Phase 3
-
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04097145 · 870 participants · NA
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
- NCT06822790 · 869 participants · Phase 3
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
- NCT06077760 · 868 participants · Phase 3
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
- NCT04933552 · 867 participants
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI