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

Conditions

• NSCLC, Stage I

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Pembrolizumab 400mg IV

Study Details

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)

Key Dates

Start date

May 5, 2020

Status verified

Apr 2026

Primary completion

Apr 8, 2027

Completion

Apr 8, 2028

Study Design

Enrollment

244 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A- Pembrolizumab
  Pembrolizumab 400mg IV every 6 weeks x 9 cycles
• No Intervention: Arm B - Observation
  Observation only

Primary Outcome Measure

Disease Free Survival (DFS) [ Time Frame: Up to 3 years from time of randomization ]

Central Contacts

• Greg Durm, MD
  317-944-3940
  [email protected]
• Allison Lipps
  317-634-5842
  [email protected]

Locations (13)

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