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New treatment option for Lung Cancer
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
ClinicalTrials.gov ID: NCT06749860
What this study is testing
What is Disitamab Vedotin + tislelizumab + bevacizumab?
Disitamab Vedotin + tislelizumab + bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Prior to the implementation of any trial-related procedures, written informed consent must be obtained;
- Aged \>= 18 years;
- Patients with locally advanced (Stage III B/III C), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC) confirmed histologically...
- Provision of archived tumor tissue or tissue obtained during screening biopsy for biomarker testing, including PD-L1 expression, HER2 mutation...
- HER2 mutation, amplification, or HER2 expression (IHC 1+, 2+, or 3+);
You likely can't join if
- Currently participating in treatment clinical research treatment;
- Prior treatment with HER2 antibodies or antibody-drug conjugates;
- Received traditional Chinese medicine or immunomodulatory drugs (such as thymopeptides, interferons, interleukins, etc.) with anti-tumor indications...
- Patients undergoing EGFR-TKI treatment require a 2-week washout period;
- History of allergic reactions to any components of the investigational drug;
- Presence of clinically significant active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal...
See the full eligibility criteria
- Prior to the implementation of any trial-related procedures, written informed consent must be obtained;
- Aged \>= 18 years;
- Patients with locally advanced (Stage III B/III C), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC) confirmed histologically or cytologically, who are ineligible for surgical intervention and...
- Provision of archived tumor tissue or tissue obtained during screening biopsy for biomarker testing, including PD-L1 expression, HER2 mutation status, etc.;
- HER2 mutation, amplification, or HER2 expression (IHC 1+, 2+, or 3+);
- Investigator confirmation of at least one measurable lesion according to RECIST 1.1 criteria;
- Cohort I: Patients who have received prior ≥1 line of systemic therapy or HER2 tyrosine kinase inhibitors such as afatinib, pyrotinib, or pozitinib. Cohort II: No prior receipt of any systemic anti-tumor therapy for...
- Expected life expectancy \>= 3 months;
- ECOG PS 0-1;
- Adequate hematologic function, defined as an absolute neutrophil count \>= 1.5×10\^9/L, platelet count \>= 100×10\^9/L, hemoglobin \>= 90g/L (without a history of blood transfusion in the past 7 days);
- Adequate liver function, defined as total bilirubin level \<= 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \<= 2.5 times ULN for all patients...
- Adequate renal function, defined as serum creatinine \<= 1.5 times ULN;
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) \<= 1.5 times ULN; if a subject is on anticoagulant therapy, INR/PT should be within the therapeutic range set by...
- Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment, with negative results; and reliable contraception methods (such as intrauterine devices, oral contraceptives...
- Willingness to comply with regular follow-up visits and adhere to trial requirements.
- Currently participating in treatment clinical research treatment;
- Prior treatment with HER2 antibodies or antibody-drug conjugates;
- Received traditional Chinese medicine or immunomodulatory drugs (such as thymopeptides, interferons, interleukins, etc.) with anti-tumor indications within the 2 weeks preceding the first dose;
- Patients undergoing EGFR-TKI treatment require a 2-week washout period;
- History of allergic reactions to any components of the investigational drug;
- Presence of clinically significant active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention;
- Presence of clinically uncontrollable pleural effusion/ascites (patients not requiring drainage or with no significant increase in effusion for 3 days may be eligible);
- Tumor compression of vital surrounding organs (such as the esophagus) accompanied by relevant symptoms, compression of the superior vena cava, or invasion of major mediastinal vessels, heart, etc.;
- Severe complications such as a history of severe pulmonary or cardiac diseases; occurrence of any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, including myocardial infarction, unstable...
- Known presence of brain metastases. Asymptomatic or stable patients with brain metastases, as judged by the investigator, may be eligible;
- Received systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine...
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis associated with...
- Active systemic infections, including tuberculosis (clinically diagnosed based on medical history, physical examination, imaging findings, and routine TB examinations), hepatitis B (known positive for hepatitis B...
- Known psychiatric disorders or substance abuse that may affect compliance with trial requirements;
- Recent use of a sufficient dose of oral or non-oral anticoagulants or thrombolytic agents. Prophylactic use of anticoagulants is allowed;
- History, diseases, treatments, or laboratory abnormalities that may interfere with trial results, hinder the subject's full participation in the study, or are deemed by the investigator to be against the subject's best...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.