Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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)

NCT04380636 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 870 participants
Start Date 2020-07-06
Est. Completion 2027-02-15
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 870 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04380636 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04380636?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial