Combining Vebreltinib and PLB1004 for advanced lung cancer with specific mutations

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Liang Lin
• Email: linliang@avistonebio.com
• Phone: +86-10-84148931

Similar studies

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

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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.