Last updated on August 2020

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)

Brief description of study

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 blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (OS).

Clinical Study Identifier: NCT03425643

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PPG-Oncology ( Site 0043)

Fort Wayne, IN United States
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Mayo Clinic ( Site 0026)

Rochester, MN United States
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Fundacion Favaloro ( Site 0128)

Ciudad de Buenos Aires, Argentina
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National Cancer Center ( Site 0702)

Gyeonggi-do, Korea, Republic of
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Wits Clinical Research ( Site 0570)

Parktown-Johannesburg, South Africa
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Freeman Hospital ( Site 0444)

Newcastle upon Tyne, United Kingdom
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MSKCC-Bergen ( Site 0075)

Montvale, NJ United States
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Recruitment Status: Open

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