Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorAvistone Biotechnology Co., Ltd.
Industry-sponsored
Drugs / interventionsVebreltinib
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedAugust 7, 2024
Main results expectedOctober 31, 2026
Study endsJuly 31, 2027
Registry record updatedMay 21, 2025
Trial IDNCT06574347 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

  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.