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Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm

NCT04317534

This study is recruiting at 13 US sites in 12 states, according to its ClinicalTrials.gov record last updated .

Summary

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 (\ 2-4 cm)

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • NSCLC, Stage I

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Greg Durm, MD
Last updated on ClinicalTrials.gov
May 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • Moffit Cancer Center · Tampa, FL

Illinois · 1

  • University of Illinois Cancer Center · Chicago, IL

Indiana · 1

  • Indiana University Melvin and Bren Simon Cancer Center · Indianapolis, IN

Iowa · 1

  • University of Iowa Hospitals and Clinics · Iowa City, IA

Minnesota · 1

  • University of Minnesota · Minneapolis, MN

Nebraska · 1

  • University of Nebraska Medical Center · Omaha, NE

New Jersey · 1

  • Rutgers Cancer Institute of New Jersey · New Brunswick, NJ

Ohio · 1

  • Ohio State University Comprehensive Cancer Center · Columbus, OH

Oregon · 1

  • Providence Health & Services - Oregon · Portland, OR

Pennsylvania · 1

  • Penn State Cancer Institute · Hershey, PA

Virginia · 2

  • University of Virginia Health System · Charlottesville, VA
  • Virginia Commonwealth University · Richmond, VA

Wisconsin · 1

  • Univeristy of Wisconsin · Madison, WI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.