Lung cancer
Conditions
Interventions
Experimental Group:trastuzumab rezetecan (SHR-A1811) combined with bevacizumab
Sponsors
Cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = first-line anti-tumor treatment; 6. The expected survival period is >=3 months; 7. Patients with asymptomatic or treated and stable central nervous system (CNS) metastases need to meet the following conditions: There should be no imaging progression for at least 4 weeks after the end of treatment (2) Complete the treatment 4 weeks before enrollment (3) No systemic corticosteroid hormone (> 10mg/ day prednisone or equivalent dose) treatment was required within 2 weeks before enrollment 8. Her2-variant non-small cell lung cancer confirmed by histopathology (according to the 2015 classification of the World Health Organization); NGS gene or IHC testing confirmed the presence of HER2 variations. HER2 variations include the following three types: (1) HER2 mutation (NGS test results of tissue/blood samples recognized by CLIA or CAP certification institutions); (2) HER2 primary amplification (NGS test results or FISH test results of tissue/blood samples from recognized CLIA or CAP certification institutions); (3) The criteria for interpreting HER2 protein overexpression refer to the criteria for gastric cancer 9. Normal functions of major organs, that is, meeting the following criteria: (1) Blood routine (no hematopoietic stimulating factor drugs received and no blood transfusion within 14 days before the first study treatment) : Absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >= 90g/L (2) Liver function: aspartate transferase (AST) and alanine aminotransferase (ALT) should be less than or equal to 2.5 ×ULN (for patients with liver metastasis, AST and ALT should be less than or equal to 5×ULN); Serum total bilirubin (TBIL) =3 g/dL; (3) Renal function: Serum creatinine (Cr) =50 mL/min (4) Coagulation function: international normalized ratio (INR) <=1.5, Prothrombin Time (Prothrombin Time) PT) and activated partial thromboplastin time (APTT) <=1.5 × ULN; 10. Have the ability to give informed consent, voluntarily join this study, sign the informed consent form and date it, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and NSCLC, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma. 2. Prior treatment with an antibody-drug conjugate (ADC) payloaded with a topoisomerase I inhibitor. Concurrent presence of other driver gene mutations for which approved targeted therapies are available. 3. Prior treatment with bevacizumab. 4. Radiographic evidence (CT or MRI) of tumor invasion into major blood vessels or ill-defined tumor-vessel borders; or presence of any pulmonary cavitary or necrotic lesions, as determined by the investigator. 5. Poorly controlled hypertension despite antihypertensive medication (sitting systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg), or history of hypertensive crisis or hypertensive encephalopathy. 6. History of Grade 2 or higher hemoptysis (>= 2.5 mL per event) within 3 months prior to enrollment. 7. Arterial thromboembolic events within 3 months prior to enrollment, or Grade 3 and above venous thromboembolic events within 3 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism. 8. Severe vascular disease within 6 months prior to enrollment (including aortic aneurysm requiring surgical intervention or arterial thrombosis). 9. Active brain metastases or leptomeningeal metastases. Spinal cord compression not radically treated or relieved by surgery and/or radiotherapy, or patients with previously diagnosed spinal cord compression resulting in paraparesis or paraplegia after treatment. Patients with liver metastases who underwent cryoablation or radiofrequency ablation and still have significant clinical symptoms and abnormal liver function within 4 weeks prior to enrollment. 10. Any active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism; hypothyroidism stable on hormone replacement therapy is eligible). Patients with childhood asthma that is completely resolved and requires no intervention in adulthood, or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) are eligible. Patients requiring bronchodilators for medical intervention are not eligible. Active tuberculosis. 11. Active systemic infection, such as: HIV infection; active hepatitis B (HBV DNA >= 500 IU/mL); hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and C. 12. Uncontrolled third-space fluid accumulation requiring repeated drainage (e.g., large pleural effusion, ascites, or pericardial effusion). 13. 24-hour urine protein = 1 g, or severe hepatic or renal impairment. 14. Treatment with anti-cancer vaccines or other immunostimulatory anti-cancer agents (e.g., interferon, interleukin, thymosin, cellular immunotherapy) within 1 month prior to the first dose of study treatment. 15. Concurrent participation in another clinical trial, or the time from the last dose of the previous clinical trial is less than 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to the first dose in this study. 16. History of other active malignancies within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;Disease Control Rate;Duration of Response;safety; | — |
Countries
China
Contacts
Public ContactWang Yan
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed