At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB-IV per AJCC 8th edition)
- ✓MET exon 14 jump mutation confirmed by NGS in central laboratory
- ✓EGFR wild-type, ALK negative, ROS1 negative, KRAS negative
- ✓At least one measurable lesion per RECIST 1.1
- ✕Unwilling to provide tumor tissue or blood samples
- ✕Prior treatment with MET inhibitors or HGF-targeted therapy
- ✕Symptomatic and neurologically unstable CNS metastases or CNS disease requiring increased steroids for control
- ✕Clinically poorly controlled pleural, abdominal or pericardial effusions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Multi-center, Single-arm Phase IIIb Confirmatory Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vebreltinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Exon 14 Mutation
In Brief
A Phase 3 clinical trial evaluating PLB1001 for Non-small Cell Lung Cancer. Currently recruiting, targeting 136 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to test if PLB1001 works well and safely in Non-small cell lung cancer patients with MET exon 14 mutation. The main questions it aims to answer are: * If it is works well in Non-small cell lung cancer patients with MET exon 14 mutation * If it is safety and tolerant in Non-small cell lung cancer patients with MET exon 14 mutation Participants will 1. be given PLB1001 200mg BID,oral. 2. be received hematology and urine and ECG examinations every 14 days (First 3 months) or every 28 days (After 3 months) 3. be received Image examination every 8 weeks(First year) or every 12 weeks(After one year)
Study Details
Timeline
Interventions
200mg BID Oral