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Not yet recruiting NCT06970782

Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure

Phase III Interventional Non-Small-Cell Lung Cancer

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, Pemetrexed plus Carboplatin or Cisplatin.
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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug Vebreltinib
    Subjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID).
  • Drug PLB1004
    Subjects will receive PLB1004 80mg orally once per day (QD).
  • Drug Pemetrexed plus Carboplatin or Cisplatin
    Subjects randomized to the control group received pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first).

Primary outcome measures

  • Progression-Free Survival (PFS) by BICR [Time frame: 2 years]
Secondary outcome measures (12)
  • Progression-Free Survival (PFS) by the investigator [Time frame: 2 years]
  • The objective response rate of the tumor (ORR) [Time frame: 2 years]
  • Duration of Response (DoR) [Time frame: 2 years]
  • The disease control rate (DCR) [Time frame: 2 years]
  • Overall Survival (OS) [Time frame: 3 years]
  • Objective Response Rate (ORR) in subjects with baseline intracranial metastases [Time frame: 2 years]
  • The Disease Control Rate (DCR) in subjects with baseline intracranial metastases [Time frame: 2 years]
  • Duration of Response (DoR) in subjects with baseline intracranial metastases [Time frame: 2 years]
  • Progression-Free Survival (PFS) in subjects with baseline intracranial metastases [Time frame: 2 years]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: 2 years]
  • Plasma concentrations of Vebreltinib and PLB1004 [Time frame: 2 years]
  • Second progression-free survival (PFS2) [Time frame: 2 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).
  • At least one measurable lesion as defined by RECIST V1.1.
  • ECOG performance status 0 to 1.

Exclusion criteria

  • 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.
  • 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.
  • Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.
  • 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
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06970782 · PLB1001/PLB1004-NSCLC-III-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗