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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
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.
The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4\~6 cycles (every 3 weeks).
Shanghai East Hospital
Shanghai, China
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).
Time frame: 2 years
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).
Time frame: 2 years
Overall Survival (OS)
The time from the date of randomization to the date of death .
Time frame: 3 years
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) .
Time frame: 2 years
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with complete response(CR), partial response(PR) and stable disease(SD).
Time frame: 2 years
Duration of Response (DoR)
Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression or death.
Time frame: 2 years
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Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as recorded on the case report form NCI CTCAE v5.0.
Time frame: 2 years