Clinical trial NCT06970782: Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure
Official title: A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Non-Small-Cell Lung Cancer
Keywords: NSCLC
Lung Cancer
MET Amplification
EGFR L858R
EGFR Exon 19 Deletion
EGFR
Lead sponsor: Avistone Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure

Detailed description: A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure

Eligibility 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. At least one measurable lesion as defined by RECIST V1.1.
5. 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. Before randomization, patients did not recover from any toxicity and/ or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] v5.0), except for hair loss and irrecoverable permanent radiation damage.
4. Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.
5. Pregnant or nursing women.

Primary outcomes:
measure: Progression-Free Survival (PFS) by BICR
timeFrame: 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS) by the investigator
timeFrame: 2 years
measure: The objective response rate of the tumor (ORR)
timeFrame: 2 years
measure: Duration of Response (DoR)
timeFrame: 2 years
measure: The disease control rate (DCR)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Objective Response Rate (ORR) in subjects with baseline intracranial metastases
timeFrame: 2 years
measure: The Disease Control Rate (DCR) in subjects with baseline intracranial metastases
timeFrame: 2 years
measure: Duration of Response (DoR) in subjects with baseline intracranial metastases
timeFrame: 2 years
measure: Progression-Free Survival (PFS) in subjects with baseline intracranial metastases
timeFrame: 2 years
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 2 years
measure: Plasma concentrations of Vebreltinib and PLB1004
timeFrame: 2 years
measure: Second progression-free survival (PFS2)
timeFrame: 2 years
measure: Assess the Quality of Healthy Living About Patients（EQ-5D-5L）
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: