A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm. Patients will be randomized (1:1) 4-12 weeks following surgery to either: * Arm A: Pembrolizumab 400 mg every 6 weeks × 9 cycles * Arm B: Observation Stratification factors will include: PD-L1 TPS (\<50% vs. ≥50%), and tumor size (1-2 cm vs. \>2-4 cm)
A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm. Patients will be randomized (1:1) 4-12 weeks following surgery to either: * Arm A: Pembrolizumab 400 mg every 6 weeks × 9 cycles * Arm B: Observation Stratification factors will include: PD-L1 TPS (\<50% vs. ≥50%), and tumor size (1-2 cm vs. \>2-4 cm) 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) with primary tumors 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. Exploratory Objectives: * 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) with primary tumors between 1-4 cm in size and a PD-L1 tumor proportion score (TPS) of ≥ 50%. * 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) with primary tumors between 1-4 cm in size and a high tumor mutation burden (TMB) defined as ≥ 10 mutations/MB. * 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) with primary tumors between 1-4 cm in size and a high tumor mutation burden (TMB) defined as ≥ 16 mutations/MB. * To evaluate the disease free survival and overall survival for patients stratified by PD-L1 status (TPS ≥ 50% vs. \< 50%), and tumor size (1-2 cm vs. \>2-4 cm). * To evaluate the association between various known prognostic variables, including, but not limited to, tumor differentiation (well-differentiated, moderately well differentiated, poorly differentiated), lymphovascular invasion, sex (male, female), PET max SUV and disease free survival and overall survival in patients treated with adjuvant Pembrolizumab for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size. * To evaluate whether the presence of circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) following surgical resection predicts relapse in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size. * To evaluate whether the presence of ctDNA or CTCs following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size can predict which patients benefit from adjuvant Pembrolizumab compared to observation. * To evaluate potential biomarkers (which may include genomics, RNA, tumor infiltrating lymphocytes, CD4 and CD8 expression, JAK2, STK11/LB1 loss of function, macrophage profile, neutrophil/lymphocyte ratio, and microbiome) as prognostic or predictive for improved disease free survival and overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Pembrolizumab 400mg IV
Moffit Cancer Center
Tampa, Florida, United States
RECRUITINGUniversity of Illinois Cancer Center
Chicago, Illinois, United States
RECRUITINGIndiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGProvidence Health & Services - Oregon
Portland, Oregon, United States
RECRUITINGPenn State Cancer Institute
Hershey, Pennsylvania, United States
RECRUITING...and 3 more locations
Disease Free Survival (DFS)
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. Median Disease Free Survival (DFS) will be reported.
Time frame: Up to 3 years from time of randomization
Overall Survival (OS)
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. Median Overall Survival will be reported
Time frame: Up to 3 years from time of randomization
1 Year Disease Free Survival Rate
To evaluate the disease-free survival rate at 1 year on each arm.
Time frame: Up to 1 year from time of randomization
1 Year Overall Survival Rate
To evaluate the overall survival rate at 1 year on each arm.
Time frame: Up to 1 year from time of randomization
2 Year Disease Free Survival Rate
To evaluate the disease-free survival rate at 2 years on each arm.
Time frame: Up to 2 years from time of randomization
2 Year Overall Survival Rate
To evaluate the overall survival rate at 2 years on each arm.
Time frame: Up to 2 years from time of randomization
3 Year Disease Free Survival
To evaluate the disease-free survival rate at 3 years on each arm.
Time frame: Up to 3 years from time of randomization
3 Year Overall Survival Rate
To evaluate the overall survival rate at 3 years on each arm.
Time frame: Up to 3 years from time of randomization
Summarize Grade 3 & 4 Adverse Events
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.
Time frame: Up to 3 years from time of randomization
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