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

NCT04317534 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-05-05

No results posted yet for this study

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)

Conditions

  • NSCLC, Stage I

Interventions

DRUG

Pembrolizumab

Pembrolizumab 400mg IV

Sponsors & Collaborators

Principal Investigators

  • Greg Durm, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2027-04-08
Completion
2028-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04317534 on ClinicalTrials.gov