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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2027-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Non-Small-Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vebreltinib 150mg BID+PLB1004 80mg QD

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.

Group Type EXPERIMENTAL

Vebreltinib

Intervention Type DRUG

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

PLB1004

Intervention Type DRUG

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

Osimertinib 80mg QD

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.

Group Type ACTIVE_COMPARATOR

Osimertinib

Intervention Type DRUG

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

Interventions

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Vebreltinib

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

Intervention Type DRUG

Osimertinib

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

Intervention Type DRUG

PLB1004

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

Intervention Type DRUG

Other Intervention Names

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Bozitinib PLB1001 AZD9291 Andamertinib

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No