At a glance
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NCT04923906Phase 3ActiveUpdate OverdueUpdated 19mo ago · Completion was 24mo agoEfficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study
In Brief
A Phase 3 clinical trial evaluating Aumolertinib and Placebo Aumolertinib for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 624 participants across 1 site.
Signals
Detailed Summary
To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
Study Details
Timeline
Interventions
Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles. Dose may be reduced to allow for the management of investigational drug related toxicity.
Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.