Actively Recruiting
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
Led by Samsung Medical Center · Updated on 2026-04-28
59
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Adults aged 30 to 75 years
- Pathologically confirmed lung adenocarcinoma with persistent GGNs in at least one other lobe, defined as ground glass-opacity with well-defined margin, mean density above -500 HU, and size greater than 7.5 mm
- Resected lung adenocarcinoma must have actionable EGFR mutation (L858R or exon 19 deletion)
- WHO performance status 0-1 without deterioration in past 2 weeks and life expectancy of at least 12 weeks
- Complete surgical resection of primary non-small cell lung cancer
- Recovery from lung cancer surgery without complications
- For treatment arm: postoperative staging of IB, II, or IIIA
- Female participants of childbearing potential must use highly effective contraception and have a negative pregnancy test before dosing or have evidence of non-childbearing potential
- Male participants must agree to use barrier contraception during the study and for 4 months after last dose
You will not qualify if you...
- Regression of synchronous GGNs after adjuvant chemotherapy before osimertinib
- History of postoperative acute lung injury, acute respiratory distress syndrome, or pneumonia during recovery
- Use of strong CYP3A4 inducers within 3 weeks prior to study start
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding disorders, or active infections such as hepatitis B, hepatitis C, or HIV
- Severe nausea, vomiting, gastrointestinal diseases, inability to swallow medication, or previous bowel surgery affecting drug absorption
- Abnormal heart rhythm or conduction issues including prolonged QTc interval over 470 msec or risk factors for arrhythmia
- History or clinical evidence of interstitial lung disease or radiation pneumonitis requiring steroid treatment
- Inadequate bone marrow or organ function based on laboratory tests
- Breastfeeding women
- Pregnant or breastfeeding women or those not using effective birth control
- Staff involved in study planning or conduct
- Hypersensitivity to osimertinib or related drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sehoon Lee
Seoul, South Korea, 06351
Actively Recruiting
Research Team
S
Sehoon Lee, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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