ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

This is a randomized, controlled, multicenter, Phase 3 clinical study designed to evaluate the efficacy and safety of ASKC202 plus limertinib (double-blind Arm A) versus osimertinib (double-blind Arm B) as first-line treatment for patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR sensitizing mutations (19Del or 21 L858R) and MET protein overexpression. In addition, Arm C (open-label) will concurrently evaluate the efficacy and safety of osimertinib plus pemetrexed and cisplatin or carboplatin as first-line treatment for patients with EGFRm+/MET+ locally advanced or metastatic non-squamous NSCLC. Eligible participants will be stratified by EGFR mutation status (19Del vs. L858R) and brain metastasis (yes vs. no) and randomly assigned in a 2:2:1 ratio to Arm A, Arm B, or Arm C. Participants in each arm will receive the corresponding study treatment (21-day cycle) until disease progression, death, intolerable toxicity, or fulfillment of any other protocol-defined treatment discontinuation criterion, whichever occurs first.