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

Korábbi kezelés

• 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;
• 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;

Más betegség

• Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption;
• Serious or uncontrolled cardiovascular disease;
• 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;

Laborértékek

• 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;

Egyéb

• Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression;
• Pregnant or lactating females;

• 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.