About this trial
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 IIB or IIIA 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).
Male/female participants who are at least 18 years of age on the day of signing informed consent with previously untreated, histologically confirmed NSCLC and histologically confirmed Stage IIB or IIIA NSCLC. (AJCC Version 8). Lymph node disease requires histologic confirmation, while T3 (rib destruction) disease requires only radiographic documentation.
Where’s this trial being run?St James’s Hospital and University Hospital Limerick
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
Merck Sharp & Dohme
Global: April 2018
|Global Recruitment Target:||786|
|Ireland Recruitment Target:||10|