Overview

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

Status:
Recruiting

Trial end date:
2026-04-01

Target enrollment:

Participant gender:

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)

Phase:

Phase 2

Details

Lead Sponsor:

Greg Durm, MD

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Pembrolizumab