RecruitingPhase 2NCT05528458

Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

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


Sponsor

Samsung Medical Center

Enrollment

59 participants

Start Date

Sep 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, phase II study 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 IB-IIIA lung adenocarcinoma.


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether osimertinib — a targeted lung cancer drug — can prevent the growth of additional small lung lesions (called ground-glass nodules, or GGNs) in patients with EGFR-mutated lung cancer who have already had surgery to remove their main tumor. **You may be eligible if...** - You are 30–75 years old - You have had confirmed lung adenocarcinoma with an EGFR mutation (specifically L858R or exon 19 deletion) and complete surgical removal of the primary tumor - You have additional persistent ground-glass nodules in at least one other part of your lung - You are in good functional health (WHO performance status 0–1) - Your cancer is stage IB–IIIA after surgery (for the treatment arm) or stage IA (for the observation arm) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You had complications recovering from surgery - You have other serious health conditions 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 Tab

Subjects have a osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection


Locations(1)

Sehoon Lee

Seoul, South Korea

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NCT05528458


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