Actively Recruiting
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
Led by Greg Durm, MD · Updated on 2026-05-05
244
Participants Needed
13
Research Sites
413 weeks
Total Duration
On this page
Sponsors
G
Greg Durm, MD
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the study
- Male or female age 18 years or older
- ECOG Performance Status of 0 or 1 within 28 days before registration
- Complete surgical removal of stage I NSCLC with negative margins between 4 and 12 weeks before registration
- Tumor size between 1.0 and 4.0 cm based on pathology
- Surgery completed at least 28 days before registration
- Baseline chest CT within 28 days of randomization showing no disease
- Available PD-L1 and NGS results or archival tissue for testing
- Adequate organ function based on screening labs within 28 days before registration
- Negative pregnancy test for females of childbearing potential within 72 hours before registration
- Women of childbearing potential must use effective contraception or be abstinent during treatment and for 120 days after last dose
- Participants positive for hepatitis B or C must meet specific treatment and viral load criteria
- HIV-infected participants must have well-controlled HIV on stable antiretroviral therapy with specific CD4 and viral load levels
- Ability to understand and comply with study procedures throughout the study
You will not qualify if you...
- Lung cancer tumor smaller than 1 cm or larger than 4 cm, or stage II-IV disease
- Tumors with actionable EGFR mutations
- Prior chemotherapy, radiation, or immunotherapy for this lung cancer
- Active additional malignancy requiring treatment within past 2 years (with some exceptions)
- Prior treatment with anti-PD-1, anti-PD-L1, or related agents
- Live or live-attenuated vaccine within 30 days before first study dose
- Participation in another investigational study within 4 weeks before study treatment
- Immunodeficiency or chronic immunosuppressive therapy exceeding 10 mg prednisone equivalent daily within 7 days before randomization
- History of allogenic tissue or organ transplant
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Active tuberculosis infection
- HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnant, breastfeeding, or planning pregnancy or fathering children during study and 120 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Moffit Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
6
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
7
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
8
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Providence Health & Services - Oregon
Portland, Oregon, United States, 97213
Actively Recruiting
10
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
11
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
12
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
13
Univeristy of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
G
Greg Durm, MD
CONTACT
A
Allison Lipps
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here