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

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.

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 1. 1;
• 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;
• Serious or uncontrolled cardiovascular disease;
• Pregnant or lactating females;
• Other primary malignancies have been diagnosed within the last 5 years, and the following conditions can be enrolled: non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ that has undergone surgery and has been cured;