Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC. (KYLIN-2)

Avistone Biotechnology

Status and phase: Enrolling; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: PLB1004; Drug: Osimertinib; Drug: Vebreltinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06574347

PLB1001/PLB1004-NSCLC-II-02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Vebreltinib 150mg BID+PLB1004 80mg QD

Experimental group

Description:

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.

Treatment:

Drug: Vebreltinib

Drug: PLB1004

Osimertinib 80mg QD

Active Comparator group

Description:

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.

Treatment:

Drug: Osimertinib