Lung CancerPhase 2NCT06749860
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
A Phase 2 study testing Disitamab Vedotin + tislelizumab + bevacizumab in people with Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Disitamab Vedotin + tislelizumab + bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 6 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot undergo curative radiochemotherapy, as per the 8th edition TNM staging classification of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- 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;
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- 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 advanced/metastatic disease; For patients who have previously received platinum-containing adjuvant/radiotherapy, neoadjuvant/radiotherapy, or radical chemoradiotherapy for advanced disease, disease progression occurs >6 months after the end of the last treatment, may participate in this study;
- 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, or for patients with liver metastasis, AST and ALT levels <= 5 times ULN;
- 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 the anticoagulant;
- 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, and condoms) should be used during the trial and for 30 days after the end of the trial. Men of childbearing potential should use condoms for contraception during the trial and for 30 days after the end of the trial;
- Willingness to comply with regular follow-up visits and adhere to trial requirements.
Who cannot join
- Currently participating in interventional 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;
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- 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 angina, cerebrovascular accident, or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within the past 3 months before enrollment;
- 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, mercaptopurine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within the 2 weeks prior to enrollment. Local, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed;
- 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 antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone replacement therapy are eligible. Patients with controlled type 1 diabetes on stable insulin regimens are eligible;
- 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 surface antigen [HBsAg] with HBV DNA >= 1000 cps/ml or its reference lower limit), hepatitis C, or human immunodeficiency virus (HIV antibody positive);
- 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 interests in participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Chunxia Su, 13601899076, susu_mail@126.com
Chunxia Su, doctor
About this study
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:
- objective response rate;
- Progression-Free Survival;
- Overall Survival;
- Disease Control Rate;
- Duration of Response.
- Conditions
- Lung Cancer
- Being tested
- Disitamab Vedotin + tislelizumab + bevacizumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin + tislelizumab + bevacizumabDrug
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 group | Role | What they receive |
|---|---|---|
| treated | Experimental | Patients with locally advanced or metastatic NSCLC who have received prior ≥1-line systemic therapy Receives: Drug: Disitamab Vedotin + tislelizumab + bevacizumab |
| treatment-navie | Experimental | Patients with locally advanced or metastatic NSCLC who have not received prior systemic therapy Receives: Drug: Disitamab Vedotin + tislelizumab + bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
It refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response (CR) and partial response (PR).
Measured: up to 1 year
Secondary outcomes (4)
Progression-Free Survival
Refers to the time from the date of initiation of combination therapy to any objectively documented tumor progression or patient death (the last follow-up time for patients lost to follow-up; Patients who are still alive at the end of the study will be the end of follow-up at the end of the study).
Measured: up to 1 year
Overall Survival
refers to the time from the start of combination therapy to the patient's death (the last follow-up time for patients who are lost to follow-up; Patients who are still alive at the end of the study will be the end of follow-up at the end of the study).
Measured: up to 1 year
Disease Control Rate
Refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response (CR), partial response (PR) and stable (SD).
Measured: 1 year
Duration of Response
The duration of a patient's life from the first documented confirmed response (CR or PR) to the first documented disease progression (PD) or death due to any cause (whichever occurs first)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start2 Feb 2024
- Primary completion6 Jun 2026 (estimated)
- Study completion6 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxia Su, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749860
- Sponsor's protocol ID
- 2023LY0833
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2023LY0833
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 6 Jun 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- objective response rate;
- Progression-Free Survival;
- Overall Survival;
- Disease Control Rate;
- Duration of Response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated | Experimental | Drug: Disitamab Vedotin + tislelizumab + bevacizumabPatients with locally advanced or metastatic NSCLC who have received prior ≥1-line systemic therapy |
| treatment-navie | Experimental | Drug: Disitamab Vedotin + tislelizumab + bevacizumabPatients with locally advanced or metastatic NSCLC who have not received prior systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 cannot undergo curative radiochemotherapy, as per the 8th edition TNM staging classification of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- 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+);
Key exclusion criteria (16 listed)
- Currently participating in interventional 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disitamab Vedotin + tislelizumab + bevacizumabDisitamab 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. | Drug | treated, treatment-navie |
Primary outcome
objective response rate
Time frame: up to 1 year
It refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response (CR) and partial response (PR).
4 secondary outcomes
Progression-Free Survival
Time frame: up to 1 year
Overall Survival
Time frame: up to 1 year
Disease Control Rate
Time frame: 1 year
Duration of Response
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin + tislelizumab + bevacizumab in people with Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunxia Su, doctor (+8613601899076, susu_mail@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.