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Trial Summary


Protocol No.CTO-BTCRC-LUN18-153
StatusSUSPENDED
Principal InvestigatorDurm, Greg
ScopeNational
PhasePhase II
Age GroupAdult
TitleA 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
DescriptionA 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 200 mg every 3 weeks × 17 cycles Arm B: Observation Stratification factors will include: PD-L1 TPS (<50% vs. ≥50%), and tumor size (1-2 cm vs. >2-4 cm)
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Pathological tumor size must be 1.0 - 4.0 cm in greatest dimension.
  • No prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLung
Participating InstitutionsIndiana University (IU)
    Roudebush VA Medical Center
      Treatment TypeTreatment
      ContactPhone: (317) 278-5632
      Email: iutrials@iu.edu