drugset / Trial / NCT07183189

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

NCT07183189

Phase 3 Recruiting 576 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.

Timeline

Start
2025-10-30
Primary completion
2032-11
Completion
2032-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Almonertinib Small molecule Oral
Subject SHR-A2009 Other / unclassified Intravenous