Actively Recruiting
Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
Led by Samsung Medical Center · Updated on 2026-04-30
43
Participants Needed
2
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Adults aged 30 to 75 years
- Pathologically confirmed stage I lung adenocarcinoma with persistent ground-glass nodules in at least one other lung lobe
- Lung adenocarcinoma has actionable EGFR mutations limited to L858R or exon 19 deletion
- WHO performance status 0-1 with no decline in past 2 weeks and expected survival of at least 12 weeks
- Full recovery from lung cancer surgery
- Females of childbearing potential must use effective contraception, have a negative pregnancy test, and not be breastfeeding; women over 50 years or meeting specific menopause criteria considered non-childbearing
- Male participants must agree to use barrier contraception
You will not qualify if you...
- Any neoadjuvant therapy (radiation, chemotherapy, investigational or anticancer drugs) before randomization
- Any adjuvant therapy before randomization
- Extensive lung surgery beyond lobectomy or sublobar resection
- History of postoperative acute lung injury, ARDS, or pneumonia during recovery
- Current use or inability to stop strong CYP3A4 inducers prior to treatment
- Severe or uncontrolled systemic diseases or active infections including hepatitis B, hepatitis, or HIV
- Severe nausea, vomiting, gastrointestinal disease, or inability to swallow medication
- Specific cardiac conditions including prolonged QTc, certain arrhythmias, or risk factors for arrhythmia
- History or evidence of active interstitial lung disease
- Inadequate bone marrow or organ function based on specific lab criteria
- Breastfeeding women
- Pregnant or non-contracepting individuals of reproductive potential
- Involvement in study planning or conduct
- Investigator judgment that participation is unsuitable or non-compliant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
SMC
Seoul, Kangnamgu, South Korea, 06351
Actively Recruiting
2
Samsung medical center
Seoul, South Korea
Suspended
Research Team
S
Sehoon Lee, MD
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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