A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)
NCT05989542 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2025-06-29
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)
Conditions
Interventions
- DRUG
-
PLB1001
200mg BID Oral
Sponsors & Collaborators
-
Beijing Pearl Biotechnology Limited Liability Company
lead INDUSTRY
Principal Investigators
-
Yilong Wu, MD · Guangdong Provincial People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-16
- Primary Completion
- 2026-09-30
- Completion
- 2027-09-30
Countries
- China
Study Locations
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