Actively Recruiting
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
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-12-27
58
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any trial procedures
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced (Stage III B/III C), metastatic, or recurrent (Stage IV) non-small cell lung cancer not suitable for surgery or curative radiochemotherapy
- Provide archived tumor tissue or biopsy tissue for biomarker testing including PD-L1 and HER2 status
- HER2 mutation, amplification, or expression (IHC 1+, 2+, or 3+)
- At least one measurable lesion per RECIST 1.1 criteria
- Cohort I: Prior systemic therapy including HER2 tyrosine kinase inhibitors; Cohort II: No prior systemic therapy for advanced/metastatic disease except certain prior treatments with progression over 6 months
- Expected life expectancy of 3 months or more
- ECOG performance status 0-1
- Adequate hematologic function (neutrophils ≥ 1.5 x10^9/L, platelets ≥ 100 x10^9/L, hemoglobin ≥ 90 g/L)
- Adequate liver function with bilirubin ≤ 1.5 times upper limit of normal and AST/ALT ≤ 2.5 times upper limit (or ≤ 5 times if liver metastasis)
- Adequate renal function (serum creatinine ≤ 1.5 times upper limit)
- Adequate coagulation function (INR/PT ≤ 1.5 times upper limit or within therapeutic range if on anticoagulants)
- Negative pregnancy test for women of childbearing potential and use of reliable contraception during and 30 days after trial; men of childbearing potential to use condoms during and 30 days after trial
- Willing to comply with regular follow-up visits and trial requirements
You will not qualify if you...
- Participation in other interventional clinical research treatment
- Prior treatment with HER2 antibodies or antibody-drug conjugates
- Use of traditional Chinese medicine or immunomodulatory drugs with anti-tumor effects within 2 weeks before first dose
- EGFR-TKI treatment ongoing without 2-week washout
- History of allergic reactions to study drug components
- Active clinically significant hemoptysis, diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis needing intervention
- Uncontrolled pleural effusion or ascites requiring drainage or with significant increase
- Tumor compressing vital organs or major vessels with symptoms
- Severe pulmonary or cardiac disease history or recent arterial or venous thrombosis or embolism within specified timeframes
- Known brain metastases except asymptomatic or stable as judged by investigator
- Systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressive agents within 2 weeks before enrollment (local and inhaled steroids allowed)
- History of autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Active systemic infections like tuberculosis, hepatitis B or C, or HIV
- Psychiatric disorders or substance abuse affecting compliance
- Recent use of high-dose anticoagulants or thrombolytics (prophylactic use allowed)
- Other conditions or abnormalities interfering with study participation or results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
C
Chunxia Su, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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