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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: 200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
Placebo: Normal saline by IV infusion Q3W, given on cycle day 1.
Cisplatin: 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.
Gemcitabine: 1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.
Pemetrexed: 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
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).
Eligibility
Primary outcome measure(s)
- Event Free Survival (EFS) — Up to approximately 5 years
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). - Overall Survival (OS) — Up to approximately 5 years
OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).
Trial sites (227)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0028) | Gilbert | Arizona | |
| Western Regional Medical Center, Inc. ( Site 0050) | Goodyear | Arizona | |
| University of Arizona Cancer Center - Dignity Health ( Site 0062) | Phoenix | Arizona | |
| University of Arizona Cancer Center ( Site 0012) | Tucson | Arizona | |
| Pacific Cancer Medical Center, Inc. ( Site 0004) | Anaheim | California | |
| Providence Saint Joseph Medical Center ( Site 0061) | Burbank | California | |
| Pacific Cancer Care ( Site 0035) | Monterey | California | |
| John Wayne Cancer Institute ( Site 0049) | Santa Monica | California | |
| St Joseph Heritage Healthcare ( Site 0040) | Santa Rosa | California | |
| Stanford University, Stanford Cancer Center ( Site 0046) | Stanford | California | |
| Hartford Hospital ( Site 0069) | Hartford | Connecticut | |
| Helen F. Graham Cancer Center & Research Institute ( Site 0015) | Newark | Delaware | |
| Mayo Clinic Jacksonville ( Site 0022) | Jacksonville | Florida | |
| Miami Cancer Institute-Baptist Hospital ( Site 0068) | Miami | Florida | |
| Southeastern Regional Medical Center ( Site 0051) | Newnan | Georgia | |
| Northwest Oncology and Hematology ( Site 0001) | Elk Grove Village | Illinois | |
| Ingalls Memorial Hospital ( Site 0044) | Harvey | Illinois | |
| PPG-Oncology ( Site 0043) | Fort Wayne | Indiana | |
| University of Iowa Hospital and Clinics ( Site 0010) | Iowa City | Iowa | |
| Ashland-Bellefonte Cancer Center ( Site 0021) | Ashland | Kentucky | |
| Harry & Jeanette Weinberg Cancer Institute ( Site 0081) | Baltimore | Maryland | |
| Boston Medical Center ( Site 0057) | Boston | Massachusetts | |
| UMass Memorial Medical Center ( Site 0030) | Worcester | Massachusetts | |
| Henry Ford Health System ( Site 0031) | Detroit | Michigan | |
| Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034) | Lansing | Michigan | |
| Mayo Clinic ( Site 0026) | Rochester | Minnesota | |
| St. Vincent Healthcare Frontier Cancer Center ( Site 0005) | Billings | Montana | |
| University of Nebraska Medical Center ( Site 0047) | Omaha | Nebraska | |
| Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074) | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077) | Middletown | New Jersey | |
| MSKCC-Bergen ( Site 0075) | Montvale | New Jersey | |
| St. Peter's Hospital Cancer Care Center ( Site 0039) | Albany | New York | |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076) | Commack | New York | |
| Memorial Sloan Kettering Cancer Center Westchester ( Site 0079) | Harrison | New York | |
| Memorial Sloan Kettering Cancer Center ( Site 0060) | New York | New York | |
| Stony Brook University Medical Center - Cancer Center ( Site 0019) | Stony Brook | New York | |
| Montefiore Einstein Center ( Site 0016) | The Bronx | New York | |
| Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078) | Uniondale | New York | |
| White Plains Hospital Center for Cancer Care ( Site 0007) | White Plains | New York | |
| Southwestern Regional Medical Center, Inc. ( Site 0054) | Tulsa | Oklahoma |
+ 187 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03425643 on ClinicalTrials.gov ↗ ← All trials in Poland