Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Phase 2RecruitingNCT06574347

Avistone Biotechnology Co., Ltd.120 enrolled

Overview

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Non-Small-Cell Lung Cancer

Interventions

VebreltinibDRUG

Subjects will receive Vebreltinib orally twice per day (BID).

OsimertinibDRUG

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

PLB1004DRUG

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

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. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) . 5. At least one measurable lesion as defined by RECIST V1.1. 6. 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. Pregnant or nursing women.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

The objective response rate of the tumor (ORR)

The incidence of confirmed complete response or partial response.

Time frame: 2 Years

Secondary Outcomes

The disease control rate (DCR)

The incidence of complete response, partial response and stable disease.

Time frame: 2 Years

Duration of Response (DoR)

The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded.

Time frame: 2 Years

Progression-free survival (PFS)

Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Time frame: 2 Years

Time to Response (TTR)

The period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).

Time frame: 2 Years

Incidence of Treatment-Emergent Adverse Events

Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Time frame: 2 Years

Central Contacts

Liang Lin

CONTACT

08-10-84148931 linliang@avistonebio.com

Data from ClinicalTrials.gov

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