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.
Willing and able to provide signed and dated informed consent;
Patients at least 18 years of age;
Locally advanced or metastatic non-small cell lung cancer (NSCLC);
Objective disease progression following prior EGFR-TKI therapy;
Prior or ongoing treatment with any c-Met target;
Previously received systemic chemotherapy;
Patients requiring continuous use of systemic immunosuppressants or systemic corticosteroids within 2 weeks prior to the first dose.
Patients who underwent other major surgical procedures other than diagnosis or biopsy within 4 weeks prior to the first dose, or who were expected to undergo major surgeries during the study period;
Parallel
ASKC202+ Limertinib
DrugASKC202 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
DrugThe standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4\~6 cycles (every 3 weeks).
Progression-Free Survival (PFS) by BIRC
Progression-free survival (PFS) using BIRC assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first).
Progression-free survival (PFS) by investigator
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first).
Overall Survival (OS)
The time from the date of randomization to the date of death .
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) .
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with complete response(CR), partial response(PR) and stable disease(SD).
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