drugset / Trial / NCT07336732

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Phase 2 Recruiting 40 enrolled Avistone Biotechnology Co., Ltd.
NaSingle-groupOpen-labelTreatment

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)

Timeline

Start
2026-03-11
Primary completion
2026-11
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PLB1004 Small molecule Oral