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ACTIVE NOT RECRUITING

NCT03425643

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

797

Start Date

2018-04-24

Completion Date

2026-06-29

Last Updated

2024-12-03

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

Pembrolizumab

200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

DRUG

Placebo

Normal saline by IV infusion Q3W, given on cycle day 1.

DRUG

Cisplatin

75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

DRUG

Gemcitabine

1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.

DRUG

Pemetrexed

500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.

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.

Locations (227)

Banner MD Anderson Cancer Center ( Site 0028)

Gilbert, Arizona, United States

Western Regional Medical Center, Inc. ( Site 0050)

Goodyear, Arizona, United States

University of Arizona Cancer Center - Dignity Health ( Site 0062)

Phoenix, Arizona, United States

University of Arizona Cancer Center ( Site 0012)

Tucson, Arizona, United States

Pacific Cancer Medical Center, Inc. ( Site 0004)

Anaheim, California, United States

Providence Saint Joseph Medical Center ( Site 0061)

Burbank, California, United States

Pacific Cancer Care ( Site 0035)

Monterey, California, United States

John Wayne Cancer Institute ( Site 0049)

Santa Monica, California, United States

St Joseph Heritage Healthcare ( Site 0040)

Santa Rosa, California, United States

Stanford University, Stanford Cancer Center ( Site 0046)

Stanford, California, United States

Hartford Hospital ( Site 0069)

Hartford, Connecticut, United States

Helen F. Graham Cancer Center & Research Institute ( Site 0015)

Newark, Delaware, United States

Mayo Clinic Jacksonville ( Site 0022)

Jacksonville, Florida, United States

Miami Cancer Institute-Baptist Hospital ( Site 0068)

Miami, Florida, United States

Southeastern Regional Medical Center ( Site 0051)

Newnan, Georgia, United States

Northwest Oncology and Hematology ( Site 0001)

Elk Grove Village, Illinois, United States

Ingalls Memorial Hospital ( Site 0044)

Harvey, Illinois, United States

PPG-Oncology ( Site 0043)

Fort Wayne, Indiana, United States

University of Iowa Hospital and Clinics ( Site 0010)

Iowa City, Iowa, United States

Ashland-Bellefonte Cancer Center ( Site 0021)

Ashland, Kentucky, United States

Harry & Jeanette Weinberg Cancer Institute ( Site 0081)

Baltimore, Maryland, United States

Boston Medical Center ( Site 0057)

Boston, Massachusetts, United States

UMass Memorial Medical Center ( Site 0030)

Worcester, Massachusetts, United States

Henry Ford Health System ( Site 0031)

Detroit, Michigan, United States

Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)

Lansing, Michigan, United States

Mayo Clinic ( Site 0026)

Rochester, Minnesota, United States

St. Vincent Healthcare Frontier Cancer Center ( Site 0005)

Billings, Montana, United States

University of Nebraska Medical Center ( Site 0047)

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)

Middletown, New Jersey, United States

MSKCC-Bergen ( Site 0075)

Montvale, New Jersey, United States

St. Peter's Hospital Cancer Care Center ( Site 0039)

Albany, New York, United States

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)

Commack, New York, United States

Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0060)

New York, New York, United States

Stony Brook University Medical Center - Cancer Center ( Site 0019)

Stony Brook, New York, United States

Montefiore Einstein Center ( Site 0016)

The Bronx, New York, United States

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)

Uniondale, New York, United States

White Plains Hospital Center for Cancer Care ( Site 0007)

White Plains, New York, United States

Southwestern Regional Medical Center, Inc. ( Site 0054)

Tulsa, Oklahoma, United States

OHSU Center for Health & Healing ( Site 1006)

Portland, Oregon, United States

UPMC Pinnacle Health System - East Location ( Site 0063)

Harrisburg, Pennsylvania, United States

Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)

Philadelphia, Pennsylvania, United States

Allegheny General Hospital ( Site 0009)

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Centers ( Site 0041)

Pittsburgh, Pennsylvania, United States

VA Pittsburgh Healthcare System ( Site 0052)

Pittsburgh, Pennsylvania, United States

Saint Francis Cancer Center ( Site 0096)

Greenville, South Carolina, United States

Emily Couric Clinical Cancer Center ( Site 0013)

Charlottesville, Virginia, United States

Inova Schar Cancer Institute ( Site 0032)

Fairfax, Virginia, United States

Virginia Cancer Specialists, PC ( Site 0080)

Fairfax, Virginia, United States

Providence Regional Cancer Partnership ( Site 0065)

Everett, Washington, United States

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

Berazategui, Buenos Aires, Argentina

Hospital Privado de Comunidad. ( Site 0130)

Mar del Plata, Buenos Aires, Argentina

Hospital Universitario Austral ( Site 0127)

Pilar, Buenos Aires, Argentina

Fundacion Favaloro ( Site 0128)

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Britanico ( Site 0125)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 0135)

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario ( Site 0131)

Rosario, Santa Fe Province, Argentina

Hospital Privado Universitario de Córdoba ( Site 0139)

Córdoba, Argentina

Sanatorio Allende ( Site 0129)

Córdoba, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)

San Juan, Argentina

Orange Health Services ( Site 0624)

Orange, New South Wales, Australia

Westmead Hospital ( Site 0621)

Westmead, New South Wales, Australia

AZ Sint-Maarten ( Site 0226)

Mechelen, Antwerpen, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)

Liège, Liege, Belgium

UZ Gent ( Site 0224)

Ghent, Oost-Vlaanderen, Belgium

AZ Nikolaas ( Site 0225)

Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0221)

Leuven, Vlaams-Brabant, Belgium

AZ Delta ( Site 0222)

Roeselare, West-Vlaanderen, Belgium

Centro Regional Integrado de Oncologia ( Site 0160)

Fortaleza, Ceará, Brazil

Instituto do Cancer do Ceara ( Site 0152)

Fortaleza, Ceará, Brazil

Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)

Brasília, Federal District, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 0150)

Natal, Rio Grande do Norte, Brazil

Hospital de Caridade de Ijui ( Site 0153)

Ijuí, Rio Grande do Sul, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao ( Site 0145)

Porto Alegre, Rio Grande do Sul, Brazil

YNOVA Pesquisa Clinica ( Site 0823)

Florianópolis, Santa Catarina, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)

Barretos, São Paulo, Brazil

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)

Rio de Janeiro, Brazil

Hospital Paulistano - Amil Clinical Research ( Site 0822)

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz ( Site 0158)

São Paulo, Brazil

Princess Margaret Cancer Centre ( Site 0109)

Toronto, Ontario, Canada

CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)

Chicoutimi, Quebec, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)

Montreal, Quebec, Canada

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0111)

Montreal, Quebec, Canada

Tianjin Medical University General Hospital ( Site 0806)

Tianjin, Anhui, China

Beijing Cancer Hospital ( Site 0810)