At a glance
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NCT06706713Phase 2RecruitingUpdate OverdueUpdated 19mo ago · Completion was 6mo agoAn Apen-label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of BEBT-109 in Patients With EGFR Exon 20 Insertion Mutations in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating BEBT-109 Capsule for Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutation. Currently recruiting, targeting 200 participants across 2 sites.
Signals
Detailed Summary
This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.
Study Details
Timeline
Interventions
Take orally before breakfast and dinner each day, with a minimum interval of 9 hours between doses, 120mg each time, twice a day,and 28 days as a treatment cycle.