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

Trial Details

NCT ID
NCT04317534
Phase
PHASE2
Sponsor
Greg Durm, MD
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Pembrolizumab
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Minneapolis, Minnesota, United States|44.97997,-93.26384

Key Eligibility Criteria

  • The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also …
  • Males and females age ≥ 18 years at the time of consent.
  • ECOG Performance Status of 0-1 within 28 days prior to registration.
  • Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical…

For full eligibility, visit ClinicalTrials.gov.

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