Actively Recruiting
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
Led by Beijing Pearl Biotechnology Limited Liability Company · Updated on 2025-06-29
136
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PLB1001, an oral drug, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a specific genetic change called MET exon 14 mutation. The study aims to find out if PLB1001 is effective and safe for this group of patients. This is a phase IIIb clinical trial that includes patients who have not had many prior treatments and meet certain health criteria. Participants will receive PLB1001 at a dose of 200 mg twice daily in 28-day cycles. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Patients will have blood tests, urine tests, and ECGs every 14 days for the first three months, then every 28 days thereafter. Imaging scans to assess the cancer will be done every 8 weeks during the first year and every 12 weeks after that. During the trial, participants will undergo regular health evaluations, including laboratory tests and imaging to monitor tumor response and safety. Researchers will measure outcomes such as confirmed tumor response rate, disease control, duration of response, and progression-free survival over two years. Safety will also be closely monitored by tracking side effects. The study expects participants to be involved for at least two years, with ongoing assessments throughout this period.
CONDITIONS
Brief Title
A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and agree to follow study visits and procedures
- Male or female aged 18 years and above
- 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 limited previous therapy (≤3 lines)
- Confirmed MET exon 14 mutation by central laboratory NGS test
- Tissue testing confirms EGFR wild-type, ALK negative, ROS1 negative, and KRAS negative
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0-1
- Expected survival of at least 3 months
- Laboratory tests within specified limits for liver, blood cells, kidney function, coagulation, and enzymes
- Ability to comply with study visits, treatments, and tests
- Use effective contraception for men and women of childbearing potential; negative pregnancy test for women prior to first dose
You will not qualify if you...
- Unwilling to provide tumor tissue or blood samples for molecular testing
- Previous treatment with MET inhibitors or HGF-targeted therapy
- Symptomatic or unstable central nervous system metastases requiring high-dose steroids
- Poorly controlled pleural, abdominal, or pericardial effusions
- Unstable or uncontrolled cardiac conditions or hypertension
- Coagulation disorders or recent serious thromboembolic events within 6 months
- Risk factors for QTc prolongation or significant heart rhythm abnormalities
- Active gastrointestinal disorders affecting drug absorption
- Active infections including hepatitis B, C, HIV, syphilis, tuberculosis, or pneumonia
- Hypersensitivity to Vebreltinib or related compounds
- Use of warfarin or coumarin anticoagulants (except low-dose warfarin)
- Unresolved toxicity from prior cancer treatments except alopecia and certain neuropathies
- Comorbid conditions increasing risk of toxicity
- Recent antineoplastic or investigational drug therapy within specified washout periods
- Recent chest radiotherapy or major surgery within specified timeframes
- Other malignancies diagnosed within last 3 years requiring treatment
- Use of CYP3A4 inducers or inhibitors that cannot be stopped
- Pregnant or breastfeeding
- Participation in another interventional trial or investigational drug use within 2 weeks
- Other investigator-determined conditions making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive 200mg of PLB1001 twice daily in 28-day cycles until disease progression, death, adverse event leading to discontinuation, or withdrawal of consent.
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Weizhe Xue, Ph.D
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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