Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-043
Prinicipal Investigator
Ma, Patrick
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
BTCRC-LUN18-153
Title
A randomized phase II trial of adjuvant Pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153
Objective
Primary Objective
To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) that is between 1- 4 cm in size, regardless of PD-L1 TPS score.

Secondary Objectives
To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves overall survival compared with observation in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS.

To evaluate the disease-free survival and overall survival rates at 1 year, 2 years, and 3 years on each arm.

To characterize the toxicity profile of adjuvant Pembrolizumab following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size.
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center