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.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS) by BIRC
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •EGFR mutation with MET amplification/Overexpression by a central laboratory;
- •Measurable lesions based on RECIST
- •ECOG performance status 0 or 1;
- •Expected survival \>12 weeks;
- •Adequate bone marrow reserve or organ function.
Exclusion Criteria
- •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;
- •Prior to the first administration, there are unhealed toxic reactions of ≥ grade 2 (CTCAE 5.0 standard) associated with any previous treatment, any level of hair loss, and platinum drugs Except for grade 2 neuropathy caused;
- •Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression;
- •Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption;
- •Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD；
- •Have previously received hematopoietic stem cell transplants or solid organ transplants, or plan to receive hematopoietic stem cell transplants or solid organ transplants during the current period of study;
- •There are serious or active infections that required intravenous antibiotics or hospitalization, such as HBV (HBsAg-positive and peripheral HBV-DNA titer test≥1×104 copies/mL or 2000 IU/mL), HCV, HIV, and syphilis;
Arms & Interventions
ASKC202 + Limertinib
ASKC202+Limertinib
Intervention: ASKC202+ Limertinib (Drug)
Pemetrexed + Cisplatin /Carboplatin
Pemetrexed+Cisplatin/Carboplatin
Intervention: Pemetrexed + Cisplatin /Carboplatin (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) by BIRC
Time Frame: 2 years
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).
Secondary Outcomes
- Progression-free survival (PFS) by investigator(2 years)
- Overall Survival (OS)(3 years)
- Objective Response Rate (ORR)(2 years)
- Disease Control Rate (DCR)(2 years)
- Duration of Response (DoR)(2 years)
- Incidence and severity of treatment-emergent adverse events(2 years)