drugset / Trial / NCT06671379

A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC

NCT06671379 ↗

Phase 3 Active not recruiting 498 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.

Timeline

Start
2024-11-29
Primary completion
2026-12
Completion
2027-06

Outcome

Met primary endpoint

release “研究结果显示,注射用瑞康芦泽妥塔单抗较含铂双药化疗,可显著延长患者的PFS” hengrui.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule — Intravenous
Comparator Cisplatin Other / unclassified — Intravenous
Comparator Pemetrexed Small molecule — Intravenous
Subject SHR-A2009 Other / unclassified — Intravenous