RecruitingPhase 2NCT04410796

Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients With Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

571 participants

Start Date

May 28, 2020

Study Type

INTERVENTIONAL

Conditions

Metastatic Non Small Cell Lung Cancer

Summary

This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding chemotherapy to the targeted therapy drug osimertinib improves outcomes for people with metastatic (spread) non-small cell lung cancer that has a specific genetic change called an EGFR mutation. **You may be eligible if...** - You are 18 or older - You have metastatic non-small cell lung cancer with an EGFR mutation confirmed by biopsy - You have not yet started EGFR-targeted therapy, or started osimertinib within the last 3 weeks - You have not received chemotherapy for your metastatic disease - You are in good enough health to receive treatment (Karnofsky score ≥ 70%) - You can swallow pills and your organ function is adequate **You may NOT be eligible if...** - You have already been treated with EGFR-targeted therapy (other than recent osimertinib) - You have already received chemotherapy for metastatic disease - You have active brain metastases requiring immediate treatment 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

DRUGOsimertinib

80mg orally daily

DRUGCarboplatin

Carboplatin (AUC 5 IV q 3 weeks)

DRUGPemetrexed

Pemetrexed (500mg/m2 IV q 3 weeks) for a total of 4 cycles

Locations(18)

UC Davis Cancer Center (Data Collection Only)

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

John Hopkins Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Limited protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States

New York University

New York, New York, United States

Columbia University (Data Collection Only)

New York, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD ANDERSON CANCER CENTER (Data Collection Only)

Houston, Texas, United States

University of Washington (Data Collection Only)

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04410796

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