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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 II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell
Lung Cancer (NSCLC) (KEYNOTE-671)
Primary Objective:
To evaluate event-free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using RECIST 1.1 assessed by blinded independent central review (BICR).
To evaluate the overall survival (OS).
Secondary Objective:
To evaluate the rate of major pathological response (mPR) assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab.
To evaluate the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab.
To evaluate mean change from baseline in the neoadjuvant phase and in the adjuvant phase in global health status/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ)-C30.
To evaluate the safety and tolerability of NAC plus pembrolizumab followed by surgery and adjuvant pembrolizumab.
Tertiary/Exploratory Objectives
To evaluate changes in health-related QoL assessment from baseline in the neoadjuvant phase and in the adjuvant phase.
To characterize health utilities in neoadjuvant and adjuvant phases using EuroQol EQ-5D-5L.
To identify molecular (genomic, metabolic and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of pembrolizumab
plus chemotherapy used as neoadjuvant and in combination with pembrolizumab as adjuvant.
Primary Objective:
To evaluate event-free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using RECIST 1.1 assessed by blinded independent central review (BICR).
To evaluate the overall survival (OS).
Secondary Objective:
To evaluate the rate of major pathological response (mPR) assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab.
To evaluate the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab.
To evaluate mean change from baseline in the neoadjuvant phase and in the adjuvant phase in global health status/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ)-C30.
To evaluate the safety and tolerability of NAC plus pembrolizumab followed by surgery and adjuvant pembrolizumab.
Tertiary/Exploratory Objectives
To evaluate changes in health-related QoL assessment from baseline in the neoadjuvant phase and in the adjuvant phase.
To characterize health utilities in neoadjuvant and adjuvant phases using EuroQol EQ-5D-5L.
To identify molecular (genomic, metabolic and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of pembrolizumab
plus chemotherapy used as neoadjuvant and in combination with pembrolizumab as adjuvant.
Recruitment Status
Past Studies