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)
Public ClinicalTrials.gov record NCT03425643. 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 III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03425643
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 797 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Placebo Drug
- Cisplatin Drug
- Gemcitabine Drug
- Pemetrexed Drug
Biological · Drug
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
- Apr 24, 2018 (Actual)
- Primary completion
- Jul 10, 2023 (Actual)
- Completion
- Oct 15, 2026 (Estimated)
- Last update posted
- Jul 29, 2026
2018 – 2026
United States locations
- U.S. sites
- 51
- U.S. states
- 24
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0028) | Gilbert | Arizona | 85234 | — |
| Western Regional Medical Center, Inc. ( Site 0050) | Goodyear | Arizona | 85338 | — |
| University of Arizona Cancer Center - Dignity Health ( Site 0062) | Phoenix | Arizona | 85004 | — |
| University of Arizona Cancer Center ( Site 0012) | Tucson | Arizona | 85724 | — |
| Pacific Cancer Medical Center, Inc. ( Site 0004) | Anaheim | California | 92801 | — |
| Providence Saint Joseph Medical Center ( Site 0061) | Burbank | California | 91505 | — |
| Pacific Cancer Care ( Site 0035) | Monterey | California | 93940 | — |
| John Wayne Cancer Institute ( Site 0049) | Santa Monica | California | 90404 | — |
| St Joseph Heritage Healthcare ( Site 0040) | Santa Rosa | California | 95403 | — |
| Stanford University, Stanford Cancer Center ( Site 0046) | Stanford | California | 94305 | — |
| Hartford Hospital ( Site 0069) | Hartford | Connecticut | 06102 | — |
| Helen F. Graham Cancer Center & Research Institute ( Site 0015) | Newark | Delaware | 19718 | — |
| Mayo Clinic Jacksonville ( Site 0022) | Jacksonville | Florida | 32224 | — |
| Miami Cancer Institute-Baptist Hospital ( Site 0068) | Miami | Florida | 33176 | — |
| Southeastern Regional Medical Center ( Site 0051) | Newnan | Georgia | 30265 | — |
| Northwest Oncology and Hematology ( Site 0001) | Elk Grove Village | Illinois | 60007 | — |
| Ingalls Memorial Hospital ( Site 0044) | Harvey | Illinois | 60426 | — |
| PPG-Oncology ( Site 0043) | Fort Wayne | Indiana | 46845 | — |
| University of Iowa Hospital and Clinics ( Site 0010) | Iowa City | Iowa | 52242 | — |
| Ashland-Bellefonte Cancer Center ( Site 0021) | Ashland | Kentucky | 41101 | — |
| Harry & Jeanette Weinberg Cancer Institute ( Site 0081) | Baltimore | Maryland | 21237 | — |
| Boston Medical Center ( Site 0057) | Boston | Massachusetts | 02118 | — |
| UMass Memorial Medical Center ( Site 0030) | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System ( Site 0031) | Detroit | Michigan | 48202 | — |
| Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034) | Lansing | Michigan | 48912 | — |
| Mayo Clinic ( Site 0026) | Rochester | Minnesota | 55905 | — |
| St. Vincent Healthcare Frontier Cancer Center ( Site 0005) | Billings | Montana | 59102 | — |
| University of Nebraska Medical Center ( Site 0047) | Omaha | Nebraska | 68198-7680 | — |
| Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074) | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077) | Middletown | New Jersey | 07748 | — |
| MSKCC-Bergen ( Site 0075) | Montvale | New Jersey | 07645 | — |
| St. Peter's Hospital Cancer Care Center ( Site 0039) | Albany | New York | 12208 | — |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076) | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center Westchester ( Site 0079) | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0060) | New York | New York | 10065 | — |
| Stony Brook University Medical Center - Cancer Center ( Site 0019) | Stony Brook | New York | 11794-9447 | — |
| Montefiore Einstein Center ( Site 0016) | The Bronx | New York | 10461 | — |
| Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078) | Uniondale | New York | 11553 | — |
| White Plains Hospital Center for Cancer Care ( Site 0007) | White Plains | New York | 10601 | — |
| Southwestern Regional Medical Center, Inc. ( Site 0054) | Tulsa | Oklahoma | 74133 | — |
| OHSU Center for Health & Healing ( Site 1006) | Portland | Oregon | 97239 | — |
| UPMC Pinnacle Health System - East Location ( Site 0063) | Harrisburg | Pennsylvania | 17109 | — |
| Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053) | Philadelphia | Pennsylvania | 19124 | — |
| Allegheny General Hospital ( Site 0009) | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Hillman Cancer Centers ( Site 0041) | Pittsburgh | Pennsylvania | 15232 | — |
| VA Pittsburgh Healthcare System ( Site 0052) | Pittsburgh | Pennsylvania | 15240 | — |
| Saint Francis Cancer Center ( Site 0096) | Greenville | South Carolina | 29607 | — |
| Emily Couric Clinical Cancer Center ( Site 0013) | Charlottesville | Virginia | 22903 | — |
| Inova Schar Cancer Institute ( Site 0032) | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists, PC ( Site 0080) | Fairfax | Virginia | 22031 | — |
| Providence Regional Cancer Partnership ( Site 0065) | Everett | Washington | 98201 | — |
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 176 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03425643, 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 Jul 29, 2026 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03425643 live on ClinicalTrials.gov.