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Aumolertinib + Phased Chemotherapy in EGFR L858R-Mutated Lung Adenocarcinoma (ACCEL)
NCT07624487Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Taipei Medical University Hospital
- Drugs
- almonertinib
- Conditions
- lung adenocarcinoma
01
Overview
Phase 2, open-label, single-arm trial of almonertinib in lung adenocarcinoma, sponsored by Taipei Medical University Hospital. Primary endpoints: Molecular response at 18 weeks and Progression-Free Survival. Started Jun 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
EGFR-TKI with phased chemotherapy
Aumolertinib induction, followed by aumolertinib + chemotherapy consolidation, followed by aumolertinib maintenance
03
Who it enrols
Treatment-naïve patients >= 18 years with advanced/metastatic lung adenocarcinoma harboring EGFR L858R mutation, ECOG PS 0-2, adequate organ function, and no prior systemic therapy for advanced disease.
04
Endpoints
Primary
Molecular response
Progression-Free Survival
Secondary
Objective Response Rate
Disease Control Rate
Adverse Events
Molecular Clearance Rate
Shifts in circulating immune cell populations
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