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

Phase 3Not Yet RecruitingNCT06970782

Avistone Biotechnology Co., Ltd.278 enrolled

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

278

Conditions

Non-Small-Cell Lung Cancer

Interventions

VebreltinibDRUG

Subjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID).

PLB1004DRUG

Subjects will receive PLB1004 80mg orally once per day (QD).

Pemetrexed plus Carboplatin or CisplatinDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Progression-Free Survival (PFS) by BICR

Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors.

Time frame: 2 years

Secondary Outcomes

Progression-Free Survival (PFS) by the investigator

Refer to RECIST v1.1, PFS assessed by the investigator.

Time frame: 2 years

The objective response rate of the tumor (ORR)

Refer to RECIST v1.1, ORR assessed by the investigator and BICR.

Time frame: 2 years

Duration of Response (DoR)

Refer to RECIST v1.1, DoR assessed by the investigator and BICR.

Time frame: 2 years

The disease control rate (DCR)

Refer to RECIST v1.1, DCR assessed by the investigator and BICR.

Time frame: 2 years

Overall Survival (OS)

OS is defined as the time from the date of the first dose until the date of death due to any cause.

Time frame: 3 years

Objective Response Rate (ORR) in subjects with baseline intracranial metastases

Refer to RECIST v1.1，ORR assessed by the investigator and BICR.

Time frame: 2 years

The Disease Control Rate (DCR) in subjects with baseline intracranial metastases

Refer to RECIST v1.1, DCR assessed by the investigator and BICR.

Central Contacts

Liang Lin

CONTACT

+86-10-84148931 linliang@avistonebio.com

Data from ClinicalTrials.gov

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