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Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations
Sponsor: Avistone Biotechnology Co., Ltd.
Summary
This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)
Official title: An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-11
Completion Date
2029-01
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
PLB1004
Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy
Locations (1)
Sun Yat-Sen University Cancer Center
Guangzhou, China