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

Sponsor
Samsung Medical Center
Study ID
NCT05528458
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

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

Study Design

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

Arms

  • Experimental: Osimertinib
    Subjects should continue on study treatment until objective disease progression, or for three years since osimertinib administration. If progression of remaining GGN on serial CT scan, patients will receive proper treatment for progressed GGN.
  • No Intervention: Obsevation
    Subjects with confirmation of pathologic stage IA NSCLC after surgery will be allocated to the control group.

Primary Outcome Measure

To assess the efficacy of osimertinib on the regression of additional GGN(s) [ Time Frame: The imaging modalities used for GGN assessments will be CT scan (1 mm thin-section) of chest. Baseline, 12weeks, 24weeks, 36weeks, 52weeks and then every 24weeks until 5years assessments should be performed ]

Central Contacts

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