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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
Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
286
Start Date
2025-08-31
Completion Date
2028-12-31
Last Updated
2025-08-07
Healthy Volunteers
No
Conditions
Interventions
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.
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).
Locations (1)
Shanghai East Hospital
Shanghai, China