First-line treatment for advanced lung cancer with specific genetic mutations
A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
This study is testing a new combination treatment for people with advanced lung cancer that has specific genetic mutations to see if it helps them feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Drugs / interventions | Vebreltinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06574347 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Vebreltinib combined with PLB1004 as a first-line therapy for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who have specific genetic mutations (EGFRm+ and MET+). The study is multicenter, randomized, and open-label, focusing on patients with untreated EGFR mutations (exon 19 deletion or L858R) and MET overexpression. Participants will be monitored for treatment response and safety outcomes over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated locally advanced or metastatic NSCLC and specific EGFR and MET genetic mutations.
Not a fit: Patients with ALK or ROS1 mutations or those with symptomatic CNS metastases may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with specific genetic profiles of lung cancer.
How similar studies have performed: Other studies have shown promise in targeting similar genetic mutations in lung cancer, indicating potential for success with this approach.
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. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) . 5. At least one measurable lesion as defined by RECIST V1.1. 6. ECOG performance status 0 to 1. Exclusion Criteria: 1. There are mutations of ALK or ROS1. 2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control. 3. Pregnant or nursing women.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yi long Wu, MD — Guangdong Provincial People's Hospital
- Study coordinator: Liang Lin
- Email: linliang@avistonebio.com
- Phone: 08-10-84148931
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.