First-line treatment for advanced lung cancer with specific genetic mutations
Official title: 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.
Run by Avistone Biotechnology Co., Ltd. · NCT06574347 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Drugs / interventions | Vebreltinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | August 7, 2024 |
| Main results expected | October 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT06574347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with untreated locally advanced or metastatic NSCLC and specific EGFR and MET genetic mutations.
✕Probably not a fit
Patients with ALK or ROS1 mutations or those with symptomatic CNS metastases may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in targeting similar genetic mutations in lung cancer, indicating potential for success with this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Vebreltinib plus furmonertinib in EGFR-mutated NSCLC with high PD-L1
This study tests whether combining vebreltinib with furmonertinib can help people with advanced NSCLC that has EGFR mutations and very high PD-L1 expression.
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Vebreltinib plus platinum-based doublet chemotherapy for MET-positive non-squamous NSCLC
This trial will test whether adding the oral drug vebreltinib to standard platinum-based doublet chemotherapy helps people with MET-positive, previously untreated locally advanced or metastatic non-squamous NSCLC.
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Combining Vebreltinib and PLB1004 for advanced lung cancer with specific mutations
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.
-
Testing PLB1001 in lung cancer patients with a specific mutation
This study is testing a new drug called PLB1001 to see if it helps people with a specific type of lung cancer that has a MET exon 14 mutation.
-
Patient-specific MRD liquid biopsy for resected NSCLC
This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.
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Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.