Patients with advanced, metastatic, or recurrent non-squamous cell non-small cell lung cancer
Conditions
Interventions
Group A:15 mg/kg HOT-1010/ carboplatin/paclitaxel
Group B:15 mg/kg bevacizumab/carboplatin/paclitaxel
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old (including boundary value), gender is not limited; 2. Non-squamous cell and non-small cell lung cancer diagnosed by histopathology and/or cytology with locally advanced, metastatic, or recurrent progression after local therapy that is inoperable (stage IIIB-IV, the 8th edition of lung cancer staging, see Appendix 5; If multiple tumor components are mixed, the main cell types are classified); 3. At least 1 measurable lesion according to RECIST 1.1 criteria; And the lesion had not received radiation therapy; 4. Never received systemic chemotherapy, antiangiogenic agents, or molecular-targeted agents for the primary or metastases [Note: Subjects with prior adjuvant therapy allowed, but no progression or recurrence during adjuvant therapy and 6 months after completion (including boundary values)]; 5. Wild-type EGFR is confirmed by histology or cytology (if tumor tissue specimens are not available or tissue sample size is insufficient, peripheral circulating tumor cell DNA test results may be accepted, tumor tissue test is preferred) or previously known EGFR test results are wild-type; 6. ECOG Physical Strength score 0-1; 7. Expected survival >=6 months; 8. The subjects had recovered damage from other local treatments, including radiation or surgery > 4 weeks, and the wounds had healed completely; 9. Has full organ function: ? Blood routine: white blood cell count >=3.0×10^9/L, absolute value of neutrophil (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, and hemoglobin >=90g/L; ? Liver function: total bilirubin =50mL/min; ? urinary protein =2 (+), 24-hour urine protein test is required. If the 24-hour urine protein quantity is <= 1.0g, it is allowed to be included in the group. Coagulation function: International standardized ratio (INR) <=1.5, and partial prothrombin time (PTT or APTT) <=1.5 times the upper limit of normal; 10. Fertile women had a negative blood pregnancy test, and fertile subjects (including male subjects) had no pregnancy plans and were voluntarily using effective contraception during the study period and within 6 months (including the boundary value) after the last dose of the study drug; 11. Volunteer to participate in the study and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1. Mixed non-small cell and small cell carcinoma, or mixed adenosquamous cell carcinoma with squamous cell as the main component; 2. Known positive ALK fusion gene or positive screening test results; 3. People with a tendency to bleed, a high risk of bleeding, or a clotting disorder, including thrombotic disease and/or pulmonary hemorrhage, hemoptysis (> 3mL of bright red blood) in the 6 months before screening (including boundary values) and/or in the 3 months before screening (including boundary values); Being treated with full-dose oral or parenteral anticoagulants or thrombolytic agents; Use of aspirin (>325mg/ day) or other non-steroidal anti-inflammatory drugs that inhibit platelet function within 10 days prior to screening; 4. CT/MRI imaging shows tumor enveloping or invading the lumen of a large blood vessel (e.g. pulmonary artery or superior vena cava); 5. Clinically uncontrollable hypertension [systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg after combination therapy with two or more antihypertensive drugs (if a combination, by composition.), and a history of hypertensive crisis or hypertensive encephalopathy; 6. Severe cardiovascular and cerebrovascular diseases, They included cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and significant vascular disease (including, but not limited to, aortic aneurysm requiring surgical repair or recent arterial thrombosis), unstable angina, heart failure classified >=II by the New York Heart Association (NYHA), and drug absence within the 6 months prior to screening Method of controlling arrhythmias; 7. Unhealed peptic ulcers; Fracture; People who have active infection within 1 week prior to first dosing and require systemic anti-infective therapy (not for hepatitis virus infection); 8. Tracheoesophageal fistula, gastrointestinal perforation or fistula, and intraperitoneal abscess were present in the 6 months prior to screening (including boundary values); 9. Patients with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence of uncontrolled central nervous system metastasis or meningeal metastasis, were judged by the investigators to be unsuitable for inclusion; 10. Patients who received chest radiotherapy within 4 weeks (including boundary values) prior to screening or palliative radiotherapy for bone metastases outside the chest within 2 weeks prior to screening; 11. Patients who had undergone major surgical procedures (including open chest biopsies) within 4 weeks prior to screening, had experienced major trauma, or were expected to require major surgery during the study period; 12. Minor surgical procedures (e.g., deep vein catheterization) within 48 hours of receiving study drug therapy (including boundary values); 13. Third space effusion with clinically significant symptoms (e.g. large pericardial effusion, pleural or abdominal effusion that cannot be controlled after fluid pumping or other symptomatic treatment); 14. Known allergy to bevacizumab, paclitaxel and carboplatin injections and their excipients; 15. Hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test positive subjects; If HBsAg is positive (i.e., HBsAg titers are above the normal range) and peripheral blood HBV DNA titers are negative (i.e., HBV DNA titers are within the normal range), subjects are eligible for inclusion if the investigator believes tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate at week 18; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission;Population pharmacokinetic profile in subjects;overall survival at 1 year;overall survival at 2 year;Disease control rate;overall survival;Progression free survival;Safety and immunogenicity of subjects;Objective response rate ORR at week 24; | — |
Countries
China
Contacts
Public ContactBaohui Han
Shanghai Chest Hospital
Outcome results
None listed