Phase IIIb Study to Evaluate the Safety and Effectiveness of Vebreltinib PLB1001 in Adults With Advanced or Metastatic Non-Small Cell Lung Cancer Having MET Exon 14 Mutation

What this Trial Is About

Researchers are evaluating PLB1001, an oral drug, in patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have a specific genetic change called MET exon 14 mutation. The study aims to find out if PLB1001 is effective and safe for this group of patients. This is a phase IIIb clinical trial that includes patients who have not had many prior treatments and meet certain health criteria. Participants will receive PLB1001 at a dose of 200 mg twice daily in 28-day cycles. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Patients will have blood tests, urine tests, and ECGs every 14 days for the first three months, then every 28 days thereafter. Imaging scans to assess the cancer will be done every 8 weeks during the first year and every 12 weeks after that. During the trial, participants will undergo regular health evaluations, including laboratory tests and imaging to monitor tumor response and safety. Researchers will measure outcomes such as confirmed tumor response rate, disease control, duration of response, and progression-free survival over two years. Safety will also be closely monitored by tracking side effects. The study expects participants to be involved for at least two years, with ongoing assessments throughout this period.

A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)