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NCT Number: NCT06574347

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

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

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Jinji Yang, MD

CONTACT

[email protected]

+86-20-83827812

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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.

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.
  • Pregnant or nursing women.

Treatment and study plan

Vebreltinib

Drug

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

Other names: Bozitinib, PLB1001

Osimertinib

Drug

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

Other names: AZD9291

PLB1004

Drug

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

Other names: Andamertinib

Primary outcomes

  1. The objective response rate of the tumor (ORR)

    Time frame: 2 Years

    The incidence of confirmed complete response or partial response.

Secondary outcomes

  1. The disease control rate (DCR)

    Time frame: 2 Years

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

  2. Duration of Response (DoR)

    Time frame: 2 Years

    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.

  3. Progression-free survival (PFS)

    Time frame: 2 Years

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

  4. Time to Response (TTR)

    Time frame: 2 Years

    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).

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: 2 Years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Lin

CONTACT

[email protected]

08-10-84148931

Sponsors and collaborators

Lead sponsor

Avistone Biotechnology Co., Ltd.

Industry

Registry information

Official study title

A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Acronym: KYLIN-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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