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Clinical Trials in the UK / NCT03425643
Active, not recruiting 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)

NCT03425643 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2018-04-24
Last updated
2026-07-29

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

PembrolizumabPlaceboCisplatinGemcitabinePemetrexed

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC. * If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention. * If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. * Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization. * Have adequate organ function. Exclusion Criteria: * Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor. * Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids. * Has an active infection requiring systemic therapy. * Has had an allogenic tissue/sold organ transplant. * Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients. * Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known history of Hepatitis B or Hepatitis C. * Has a known history of active tuberculosis. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate. * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor. * Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation. * Has received prior radiotherapy within 2 weeks of start of trial treatment. * Has received a live vaccine within 30 days prior to the first dose of trial drug. * Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. * Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug. * Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.

Primary outcome measure(s)

Trial sites (227)

FacilityCityRegionStatus
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

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Official registry record

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 the UK