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NCT Number: NCT06970782

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

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

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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 3

About this study

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

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).
  • 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.
  • 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.

Treatment and study plan

Vebreltinib

Drug

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

Other names: Bozitinib, PLB1001

PLB1004

Drug

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

Other names: Andamertinib

Pemetrexed plus Carboplatin or Cisplatin

Drug

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).

Primary outcomes

  1. Progression-Free Survival (PFS) by BICR

    Time frame: 2 years

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

Secondary outcomes

  1. Progression-Free Survival (PFS) by the investigator

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  3. Duration of Response (DoR)

    Time frame: 2 years

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

  4. The disease control rate (DCR)

    Time frame: 2 years

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

  5. Overall Survival (OS)

    Time frame: 3 years

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

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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  8. Duration of Response (DoR) in subjects with baseline intracranial metastases

    Time frame: 2 years

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

  9. Progression-Free Survival (PFS) in subjects with baseline intracranial metastases

    Time frame: 2 years

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

  10. 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.

  11. Plasma concentrations of Vebreltinib and PLB1004

    Time frame: 2 years

    Plasma concentrations of Vebreltinib and PLB1004.

  12. Second progression-free survival (PFS2)

    Time frame: 2 years

    Investigator-assessed second progression-free survival (PFS2).

  13. Assess the Quality of Healthy Living About Patients（EQ-5D-5L）

    Time frame: 2 years

    Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health.

    Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.

Study contacts

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

Liang Lin

CONTACT

[email protected]

+86-10-84148931

Sponsors and collaborators

Lead sponsor

Avistone Biotechnology Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: KYLIN-3

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 14, 2025
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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