A 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
Greg Durm, MD
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 (\<50% vs. ≥50%), and tumor size (1-2 cm vs. \>2-4 cm)
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection. NOTE: Initial informed consent will remain valid throughout the 12-week period between surgical resection and study registration unless, in the opinion of the treating investigator, the participant experiences a significant change in medical o…
Interventions
- DrugPembrolizumab
Pembrolizumab 400mg IV
Locations (13)
- Moffit Cancer CenterTampa, Florida
- University of Illinois Cancer CenterChicago, Illinois
- Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- University of MinnesotaMinneapolis, Minnesota
- University of Nebraska Medical CenterOmaha, Nebraska