Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT06749860
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Disitamab Vedotin + tislelizumab + bevacizumab — DRUG
    Disitamab Vedotin, dosing regimen: 2.0 mg/kg, intravenous infusion, infusion should be about 30-90 minutes (usually about 60 minutes), every 21 days a cycle, the first day of administration, continuous use. Tislelizumab, dosing regimen: 200 mg administered by intravenous infusion every 21 days in a cycle on the first day, continuous. Bevacizumab, dosing regimen; 7.5 mg/kg administered by intravenous infusion every 21 days in a cycle on the first day of continuous use.

Study Details

The goal of this clinical trial is to learn ifDisitamab Vedotin in combination with tislelizumab and bevacizumab can treat in locally advanced or metastatic non-small cell lung cancer patients with HER2 mutation/amplification/expression. The main questions it aims to answer are: 1. objective response rate; 2. Progression-Free Survival; 3. Overall Survival; 4. Disease Control Rate; 5. Duration of Response.

Key Dates

First listed
Dec 27, 2024
Start date
Feb 2, 2024
Status verified
Dec 2024
Primary completion
Jun 6, 2026
Completion
Jun 6, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treated
    Patients with locally advanced or metastatic NSCLC who have received prior ≥1-line systemic therapy
  • Experimental: treatment-navie
    Patients with locally advanced or metastatic NSCLC who have not received prior systemic therapy

Primary Outcome Measure

objective response rate [ Time Frame: up to 1 year ]

Central Contacts

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