NCT07109531

ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy

A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of ASKC202 in Combination With Limertinib Versus Platinum-based Chemotherapy in Participants With MET Amplification/Overexpression Locally Advanced or Metastatic NSCLC Who Have Failed After Prior EGFR-TKI Therapy.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the safety and efficacy of ASKC202 combined with Limertinib Versus platinum-based chemotherapy in locally advanced or metastatic NSCLC With MET Amplification/Overexpression after disease progression on EGFR tyrosine kinase inhibitor.

Detailed description

This is a randomized, controlled, open-label, multicenter, phase 3 clinical study to valuate the efficacy and safety of ASKC202 combined with Limertinib in locally advanced or metastatic NSCLC with MET amplification/overexpression after failure of EGFR inhibitor therapy. Participants will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.

Conditions

• Locally Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	ASKC202+ Limertinib	ASKC202 orally once per day (QD) combined with Limertinib orally BID for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
DRUG	Pemetrexed + Cisplatin /Carboplatin	The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4\~6 cycles (every 3 weeks).

Timeline

• Start date: 2025-08-31
• Primary completion: 2027-10-31
• Completion: 2028-12-31
• First posted: 2025-08-07
• Last updated: 2025-08-07

Locations

1 site across 1 country: China