NCT04591002 Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
| NCT ID | NCT04591002 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Samsung Medical Center |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2022-09-11 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 43 participants in total. It began in 2022-09-11 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Adult male or female patients, aged from 30 to 75 years 3. Pathologic proven stage I lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity with well-defined margin, mean density above -500 HU and greater than 7.5 mm in its maximum diameter 4. The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion. 5. WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks 6. Uneventful recovery from curative-intent lung cancer surgery 7. Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of childbearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria
Frequently Asked Questions
Who can join the NCT04591002 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04591002 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04591002 currently recruiting?
Yes, NCT04591002 is actively recruiting participants. Visit ClinicalTrials.gov or contact Samsung Medical Center to inquire about joining.
Where is the NCT04591002 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT04591002 clinical trial?
NCT04591002 is sponsored by Samsung Medical Center. The trial plans to enroll 43 participants.
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