Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05989542

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

Led by Beijing Pearl Biotechnology Limited Liability Company · Updated on 2025-06-29

136

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to sign informed consent and comply with study visits and procedures
  • Male or female aged 18 years or older
  • Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (Stage IIIB - IV)
  • No prior systemic antineoplastic therapy for advanced disease or disease progression/toxicity after no more than 3 prior therapies
  • Confirmed MET exon 14 skipping mutation by central lab NGS testing
  • Tissue test results showing EGFR wild-type, ALK rearrangement negative, ROS1 rearrangement negative, and KRAS mutation negative
  • At least one measurable lesion per RECIST 1.1 criteria
  • ECOG performance status score of 0-1
  • Expected survival of at least 3 months
  • Laboratory tests within specified limits for liver function, blood counts, coagulation, kidney function, and pancreatic enzymes
  • Investigator judges patient able to complete scheduled visits and treatments
  • Men and women of childbearing potential must use effective contraception during and for 3 months after treatment; women must have a negative pregnancy test within 7 days before first dose
Not Eligible

You will not qualify if you...

  • Unwilling to provide tumor tissue or blood samples for molecular testing
  • Prior treatment with MET inhibitors or HGF-targeted therapy
  • Symptomatic or unstable central nervous system metastases requiring increased steroids
  • Clinically poorly controlled pleural, abdominal or pericardial effusions
  • Unstable or uncontrolled cardiac conditions (e.g., unstable angina, congestive heart failure NYHA > Class II, uncontrolled hypertension)
  • Coagulation disorders or recent serious thromboembolic events within 6 months
  • Risk factors for QTc interval prolongation or significant heart rhythm abnormalities
  • Active gastrointestinal disorders interfering with drug absorption
  • Active infections including hepatitis B, hepatitis C, HIV, syphilis, tuberculosis, or recent infection requiring antibiotics
  • Known hypersensitivity to Vebreltinib or related drugs
  • Treatment with warfarin or other anticoagulants except low-dose warfarin
  • Unresolved prior antineoplastic therapy toxicities above Grade 1 except certain exceptions
  • Comorbid medical conditions increasing toxicity risk
  • Recent antineoplastic or investigational drug therapy within specified washout periods
  • Recent chest radiotherapy or major surgery without recovery
  • Another malignancy diagnosed within 3 years requiring treatment
  • Use of CYP3A4 potent inducers or inhibitors that cannot be stopped
  • Pregnant or breastfeeding
  • Participation in another interventional clinical trial or recent investigational drug use
  • Other investigator-determined conditions making study participation inappropriate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510080

Actively Recruiting

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Research Team

W

Weizhe Xue, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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