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

NCT06574347 | Recruiting Phase 2

• 1 other identifier: PLB1001/PLB1004-NSCLC-II-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Small-Cell Lung Cancer

Keywords

NSCLC; Lung Cancer; MET Amplification; EGFR L858R; EGFR Exon 19 Deletion; EGFR

Outcome Measures

Primary Outcomes (1)

• The objective response rate of the tumor (ORR)

  The incidence of confirmed complete response or partial response.

  2 Years

Secondary Outcomes (5)

• The disease control rate (DCR)

  2 Years

• Duration of Response (DoR)

  2 Years

• Progression-free survival (PFS)

  2 Years

• Time to Response (TTR)

  2 Years

• Incidence of Treatment-Emergent Adverse Events

  2 Years

Study Arms (2)

Vebreltinib 150mg BID+PLB1004 80mg QD

EXPERIMENTAL

Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Drug: Vebreltinib; Drug: PLB1004

Osimertinib 80mg QD

ACTIVE COMPARATOR

Subjects will receive Osimertinib 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Drug: Osimertinib

Interventions

Vebreltinib DRUG

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

Also known as: Bozitinib, PLB1001

Vebreltinib 150mg BID+PLB1004 80mg QD

Osimertinib DRUG

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

Also known as: AZD9291

Osimertinib 80mg QD

PLB1004 DRUG

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

Also known as: Andamertinib

Vebreltinib 150mg BID+PLB1004 80mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
• At least one measurable lesion as defined by RECIST V1.1.
• ECOG performance status 0 to 1.

You may not qualify if:

• 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.
• Pregnant or nursing women.

Sponsors & Collaborators

• Avistone Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yi long Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Lin

CONTACT

08-10-84148931; linliang@avistonebio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 27, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 21, 2025

Record last verified: 2024-08

Locations

CN (1)