RecruitingPhase 2NCT04591002

Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)

A Phase II, Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) in Other Lobes After Curative Resection for Actionable EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

Sponsor

Samsung Medical Center

Enrollment

43 participants

Start Date

Sep 11, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

Summary

This study designed to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage I lung adenocarcinoma.

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether osimertinib — a targeted lung cancer drug — can prevent small, hazy spots on the lung (called ground-glass nodules or GGNs) from growing into full cancers in patients who already had lung cancer surgery and whose original tumor had a specific gene mutation (EGFR). **You may be eligible if...** - You are between 30 and 75 years old - You had lung cancer surgery that confirmed a Stage I lung adenocarcinoma with an EGFR mutation (specifically L858R or exon 19 deletion) - You have at least one other persistent ground-glass nodule in another part of the lung - You have fully recovered from your lung surgery - Your overall health is good **You may NOT be eligible if...** - Your EGFR mutation is a type other than L858R or exon 19 deletion - You have not fully recovered from surgery - You are pregnant, breastfeeding, or not using adequate contraception - Your overall health or lung function is too impaired 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 80 MG

Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-TKI sensitising and resistance mutations in NSCLC with a significant selectivity margin over wild-type EGFR. Osimertinib will be administered orally as one 80 mg tablet once a day (1 cycle is 28 days). Cycles are repeated until disease progression, unacceptable toxicity, or until 1 year after the initiation of osimertinib administration.