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

Sponsor
Samsung Medical Center
Study ID
NCT04591002
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib 80 MG — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 11, 2022
Status verified
Apr 2026
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Osemertinib
  • No Intervention: Observation

Primary Outcome Measure

To assess the efficacy of osimertinib on the regression of additional GGN(s) [ Time Frame: up to 12months ]

Central Contacts

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