Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-23-146
Prinicipal Investigator
Komiya, Takefumi
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
019-01
Title
A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
Objective
Primary Objective: To compare MK-2870 plus pembrolizumab versus pembrolizumab monotherapy with respect to DFS as assessed by BICR.

Secondary Objectives: To compare MK-2870 plus pembrolizumab to pembrolizumab monotherapy with respect to OS. To compare MK-2870 plus pembrolizumab to pembrolizumab monotherapy with respect to OS. To evaluate MK-2870 plus pembrolizumab and pembrolizumab monotherapy with respect to DMFS as assessed by the investigator. To evaluate MK-2870 plus pembrolizumab and pembrolizumab monotherapy with respect to DFS as assessed by the investigator. To evaluate MK-2870 plus pembrolizumab and pembrolizumab monotherapy with respect to LCSS. To evaluate the safety and tolerability of MK-2870 plus pembrolizumab. To evaluate MK-2870 plus pembrolizumab and pembrolizumab monotherapy with respect to mean change from baseline in global health status/QoL, physical functioning, role functioning, and lung cancer symptoms using the EORTC QLQ-C30 and EORTC QLQ-LC24.
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center