Actively Recruiting
A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive
Led by Beijing Pearl Biotechnology Limited Liability Company · Updated on 2026-05-01
300
Participants Needed
2
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and MET-positive. The target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and MET-positive( MET Amplification or Overexpression). This study adopts an enrichment design. The enriched population is those with MET GCN ≥ 6, and the overall population is those with MET GCN ≥ 4. This study consists of two parts: the lead-in period (Part 1) and the randomized controlled period (Part 2). Both the lead-in period (Part 1) and the randomized controlled period (Part 2) will include a screening period (from Day -28 to Day -1), a treatment period (until the termination of treatment), and a follow-up period (including safety follow-up and survival follow-up).
CONDITIONS
Official Title
A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older at the time of consent.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC.
- MET-positive tumors confirmed by amplification or overexpression with required tumor tissue available.
- Tumor negative for sensitive EGFR mutations, ALK fusion, ROS1 fusion, MET exon 14 skipping mutation, and other specified mutations.
- No prior systemic therapy for locally advanced or metastatic non-squamous NSCLC.
- At least one measurable target lesion by RECIST V1.1 criteria.
- ECOG performance status of 0 or 1.
- Expected survival of at least 12 weeks.
- Good organ function including hematologic, hepatic, renal, and coagulation parameters.
- Female subjects must use adequate contraception and not breastfeed during and 90 days post-study.
- Male subjects of childbearing potential must use contraception and avoid sperm donation during and 90 days post-study.
- Ability to provide signed informed consent.
You will not qualify if you...
- Participation in another therapeutic clinical trial within 28 days prior to study dose.
- Major surgery within 28 days prior to study dose or planned surgery during study.
- Lung or brain radiotherapy within 28 days prior to study dose.
- Use of proprietary Chinese medicine with antitumor indication within 1 week prior to study dose.
- History of another primary malignancy within 3 years, excluding certain treated skin cancers or carcinoma in situ.
- Unresolved toxicity from prior therapy greater than Grade 1 except stable alopecia or skin pigmentation.
- Clinically symptomatic central nervous system metastases unless controlled and stable.
- Poorly controlled clinical third space effusions.
- Severe cardiovascular or cerebrovascular disease including abnormal QTcF, heart failure, or recent major cardiac events.
- Serious or uncontrolled systemic diseases including unstable hypertension or interstitial lung disease.
- Uncontrolled co-infections including active hepatitis B or C, HIV, syphilis, tuberculosis, or other active infections.
- Dysphagia, active gastrointestinal disease, or major GI surgery interfering with drug administration.
- Hypersensitivity to study drugs or severe allergic reactions to related chemotherapy agents.
- Receipt of live attenuated vaccines within 30 days prior to study dose.
- Known psychiatric or substance abuse disorders affecting compliance.
- Any other condition making study participation inappropriate as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Weizhe Xue, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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