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

Sponsor
Avistone Biotechnology Co., Ltd.
Study ID
NCT06574347
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vebreltinib — DRUG
    Subjects will receive Vebreltinib orally twice per day (BID).
  • Osimertinib — DRUG
    Subjects will receive Osimertinib 80mg orally once per day (QD).
  • PLB1004 — DRUG
    Subjects will receive PLB1004 80mg orally once per day (QD).

Study Details

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

Key Dates

Start date
Aug 7, 2024
Status verified
Aug 2024
Primary completion
Oct 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

The objective response rate of the tumor (ORR) [ Time Frame: 2 Years ]

Central Contacts

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