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NCT03425643 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 797
- Enrollment target
- 20
- Study locations
NCT03425643: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
NCT03425643 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 797 participants, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03425643, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 797 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).
Primary Outcome
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
Study Locations (20)
California
- Pacific Cancer Medical Center, Inc. ( Site 0004) - Anaheim
- Providence Saint Joseph Medical Center ( Site 0061) - Burbank
- Pacific Cancer Care ( Site 0035) - Monterey
- John Wayne Cancer Institute ( Site 0049) - Santa Monica
- St Joseph Heritage Healthcare ( Site 0040) - Santa Rosa
- Stanford University, Stanford Cancer Center ( Site 0046) - Stanford
Arizona
- Banner MD Anderson Cancer Center ( Site 0028) - Gilbert
- Western Regional Medical Center, Inc. ( Site 0050) - Goodyear
- University of Arizona Cancer Center - Dignity Health ( Site 0062) - Phoenix
- University of Arizona Cancer Center ( Site 0012) - Tucson
Florida
- Mayo Clinic Jacksonville ( Site 0022) - Jacksonville
- Miami Cancer Institute-Baptist Hospital ( Site 0068) - Miami
Illinois
- Northwest Oncology and Hematology ( Site 0001) - Elk Grove Village
- Ingalls Memorial Hospital ( Site 0044) - Harvey
Connecticut
- Hartford Hospital ( Site 0069) - Hartford
Delaware
- Helen F. Graham Cancer Center & Research Institute ( Site 0015) - Newark
Georgia
- Southeastern Regional Medical Center ( Site 0051) - Newnan
Indiana
- PPG-Oncology ( Site 0043) - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 797 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2026-06-29 |
| Phase | Phase 3 |
What the registry record for NCT03425643 still lists
NCT03425643 is an interventional study that assigns participants to a tested intervention. The registered 797 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03425643 names 20 study sites across 10 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03425643 about?
NCT03425643 is a clinical study titled "Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)". This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and r...
What is the current status of trial NCT03425643?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 797 participants. The study started on 2018-04-24. Estimated completion is 2026-06-29.
What conditions does trial NCT03425643 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT03425643?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03425643?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03425643 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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