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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04380636
The ClinicalTrials.gov registry entry for NCT04380636 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 870 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 317-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (174% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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