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Active (not recruiting) Phase 3 NCT03425643

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)

Phase 3 – large-scale trial before approval
Conditions: Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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).
Who can participate
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 25
Argentina (1)
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
Berazategui , Buenos Aires
Australia (1)
Orange Health Services ( Site 0624)
Orange , New South Wales
Belgium (1)
AZ Sint-Maarten ( Site 0226)
Mechelen , Antwerpen
Brazil (1)
Centro Regional Integrado de Oncologia ( Site 0160)
Fortaleza , Ceará
Canada (1)
Princess Margaret Cancer Centre ( Site 0109)
Toronto , Ontario
China (1)
Tianjin Medical University General Hospital ( Site 0806)
Tianjin , Anhui
Estonia (1)
SA Pohja-Eesti Regionaalhaigla ( Site 1100)
Tallinn , Harju
France (1)
Hopital Foch ( Site 0243)
Suresnes , Ain
Germany (1)
Klinikum Esslingen GmbH ( Site 0875)
Esslingen am Neckar , Baden-Wurttemberg
Ireland (1)
Cork University Hospital ( Site 0452)
Wilton , Cork
Italy (1)
Istituto Nazionale Tumori ( Site 0309)
Milano , Abruzzo
Japan (1)
Aichi Cancer Center Hospital ( Site 0765)
Nagoya , Aichi-ken
Latvia (1)
Pauls Stradins Clinical University Hospital ( Site 0911)
Riga
Lithuania (1)
LSMUL Kauno Klinikos ( Site 0932)
Kaunas
Malaysia (1)
Sarawak General Hospital ( Site 0782)
Kuching , Sarawak
Poland (1)
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)
Poznan , Greater Poland Voivodeship
Romania (1)
S C Pelican Impex SRL ( Site 0506)
Oradea , Bihor County
Russia (1)
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)
Chelyabinsk , Chelyabinsk Oblast
South Africa (1)
Wits Clinical Research ( Site 0570)
Parktown-Johannesburg , Gauteng
South Korea (1)
National Cancer Center ( Site 0702)
Gyeonggi-do , Kyonggi-do
Spain (1)
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)
Badalona , Barcelona
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital ( Site 0725)
Kaohsiung City
Ukraine (1)
Cherkassy Regional Oncological Center ( Site 0613)
Cherkasy , Cherkasy Oblast
United Kingdom (1)
Leicester Royal Infirmary ( Site 0447)
Leicester , Leicestershire
United States (1)
Banner MD Anderson Cancer Center ( Site 0028)
Gilbert , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.04.2018
Completion date
29.06.2026
Registry ID
NCT03425643
Source
anzctr
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