Clinical Trial

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

Study acronym: KUNPENG-2
Recruiting Phase 3
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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)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-04; most recent amendment 2025-06-25.
Status change: Active, Not Recruiting → Recruiting 2025-02-05
Trial Details
NCT Number NCT05989542
Lead Sponsor Beijing Pearl Biotechnology Limited Liability Company
Conditions Non-small Cell Lung Cancer
Enrollment 136 participants
Start Date 2023-10-16
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-29