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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Препарат Vebreltinib
  Subjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID).
• Препарат PLB1004
  Subjects will receive PLB1004 80mg orally once per day (QD).
• Препарат 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).

Первичные конечные точки

• Progression-Free Survival (PFS) by BICR [Срок оценки: 2 years]

Вторичные конечные точки (12)

• Progression-Free Survival (PFS) by the investigator [Срок оценки: 2 years]
• The objective response rate of the tumor (ORR) [Срок оценки: 2 years]
• Duration of Response (DoR) [Срок оценки: 2 years]
• The disease control rate (DCR) [Срок оценки: 2 years]
• Overall Survival (OS) [Срок оценки: 3 years]
• Objective Response Rate (ORR) in subjects with baseline intracranial metastases [Срок оценки: 2 years]
• The Disease Control Rate (DCR) in subjects with baseline intracranial metastases [Срок оценки: 2 years]
• Duration of Response (DoR) in subjects with baseline intracranial metastases [Срок оценки: 2 years]
• Progression-Free Survival (PFS) in subjects with baseline intracranial metastases [Срок оценки: 2 years]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: 2 years]
• Plasma concentrations of Vebreltinib and PLB1004 [Срок оценки: 2 years]
• Second progression-free survival (PFS2) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗