Combining Vebreltinib and PLB1004 for advanced lung cancer with specific mutations
A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
This study is testing a new combination of two drugs, Vebreltinib and PLB1004, to see if they can help people with advanced lung cancer who have certain genetic changes and haven't responded to previous treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Drugs / interventions | Vebreltinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06343064 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Vebreltinib in combination with PLB1004 for patients with advanced non-small cell lung cancer (NSCLC) who have experienced treatment failure with EGFR-TKI and have MET overexpression or amplification. It is an open-label, multicenter Phase Ib/II study that aims to assess the pharmacokinetics of the drug combination. Participants must have measurable lesions and specific genetic mutations to qualify for the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced NSCLC harboring EGFR mutations and confirmed MET overexpression or amplification.
Not a fit: Patients with previous treatment using MET inhibitors or those with certain genetic mutations like ALK or ROS1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have limited treatment alternatives.
How similar studies have performed: While this approach is novel in this specific context, similar studies targeting MET alterations in lung cancer have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Aged at least 18 years old. 3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV). 4. EGFR mutations, including exon 19 deletion and exon 21 L858R. 5. C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI. 6. At least one measurable lesion as defined by RECIST V1.1. 7. ECOG performance status 0 to 1. Exclusion Criteria: 1. Previous treatment with MET inhibitors or HGF-targeted therapy. 2. There are mutations of ALK or ROS1. 3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control. 4. Pregnant or nursing women.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Liang Lin
- Email: linliang@avistonebio.com
- Phone: +86-10-84148931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.