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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989542 on ClinicalTrials.gov