RecruitingPhase 2NCT04317534

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

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


Sponsor

Greg Durm, MD

Enrollment

244 participants

Start Date

May 5, 2020

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pembrolizumab (an immunotherapy drug) given after surgery can prevent early-stage lung cancer from coming back, compared to no additional treatment (observation only), in patients with stage I NSCLC whose tumor was between 1 and 4 cm. **You may be eligible if...** - You are at least 18 years old - You have had complete surgical removal of stage I NSCLC between 4 and 12 weeks ago - Your tumor was between 1 and 4 cm in size - Your surgical margins were clear (no cancer at the edges) - You are in good physical condition (ECOG performance status 0 or 1) - Your organ function is within normal ranges **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You are on immune-suppressing medications - You have had radiation therapy to the chest - You are pregnant or breastfeeding - You have had another cancer in the past 3 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab 400mg IV


Locations(13)

Moffit Cancer Center

Tampa, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Providence Health & Services - Oregon

Portland, Oregon, United States

Penn State Cancer Institute

Hershey, Pennsylvania, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Univeristy of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04317534


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