NCT06671379

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

A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (actual)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SHR-A2009 monotherapy	SHR-A2009 monotherapy ，SHR-A2009 will be administered intravenously
DRUG	platinum-based dual-agent chemotherapy	Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent，all drugs will be administered intravenously

Timeline

• Start date: 2024-11-29
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-11-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: China