Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vebreltinib, PLB1004.
- Who it may be relevant to
- Registry conditions: Non-Small-Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
Overview
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC
Detailed description
Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.
Interventions
- Drug Vebreltinib
Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D. - Drug PLB1004
Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according to the result of Phase Ib, will confirm the RP2D.
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). [Time frame: 3 years]
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol. [Time frame: 28 days]
- Overall Response Rate (ORR） [Time frame: 3 years]
Secondary outcome measures (4)
- Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC) [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max) [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max) [Time frame: From date of first dose up until 28 days post last dose]
- Incidence of Treatment-Emergent Adverse Events [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Ability to understand and willingness to sign a written informed consent document.
- Aged at least 18 years old.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
- EGFR mutations, including exon 19 deletion and exon 21 L858R.
- C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
- At least one measurable lesion as defined by RECIST V1.1.
- ECOG performance status 0 to 1.
Exclusion criteria
- Previous treatment with MET inhibitors or HGF-targeted therapy.
- There are mutations of ALK or ROS1.
- Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
- Pregnant or nursing women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT06343064 · PLB1001/PLB1004-NSCLC-Ib/II-01