Lung Cancer
Conditions
Interventions
Experimental group:Treated with the determined albumin paclitaxel 200-260mg/m^2, carboplatin AUC=5, bevacizumab 7.5mg/kg, intravenous infusion, every 3 weeks (Q3W), 21 days as a treatment cycle, album
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to give informed consent, signed and dated IRB/EC-approved informed consent, willing and able to comply with the planned visits for treatment and other procedural requirements; 2. Age greater than or equal to 18 years old at the time of signing the informed consent form, both male and female; 3. ECOG score is 0-1 points; 4. Expected survival >= 12 weeks; 5. Histologically confirmed advanced or metastatic non-small cell lung cancer after targeted therapy; 6. Previous receipt of EGFR-TKIs against EGFR-sensitive mutation advanced or metastatic NSCLC 7. At least one measurable lesion as defined by RECIST v1.1 criteria; 8. Vital organ function must meet the following criteria: (1) Blood routine examination: (no blood transfusion within 2 weeks before screening, no corrective treatment with cytokine drugs such as G-CSF); Hemoglobin (HB) >= 90 g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet count (PLT) >=90×10^9/L; White blood cell count (WBC) >= 3.0×109/L and =30g/L; Cr=60mL/min (Cockcroft-Gault formula); TSH = 50%. 9. Female patients who are not surgically sterilized or of childbearing age must have a serum pregnancy test within 3 days before the first dose, and the result is negative; And must be non-lactating. Female patients of childbearing potential or male patients whose partners are women of childbearing potential must agree to use highly effective methods of contraception during the study and for 6 months after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Presence of untreated or active central nervous system (CNS) tumor metastases. Subjects with a history of leptomeningeal metastasis or current leptomeningeal metastasis. Subjects with CNS metastases who have undergone adequate local treatment (surgery or radiotherapy) at least 2 weeks prior to the first dose, do not require hormonal therapy, and have neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment) may be enrolled. 2.History or concurrent diagnosis of other malignancies, except for adequately treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ after radical resection, or papillary thyroid carcinoma after radical resection (hormonal therapy for non-metastatic prostate or breast cancer is permitted), provided they have been in complete remission for at least 5 years prior to screening and require no additional treatment during the study. 3.Systemic anti-tumor therapy within 4 weeks before the start of study treatment. If prior treatment involved small-molecule targeted therapy, enrollment is permitted if the interval between treatment cessation and the first study dose is at least 5 half-lives of the drug. For prior traditional Chinese medicine (TCM) anti-tumor therapy, a washout period of at least 2 weeks is required. 4.Imaging-confirmed tumor invasion of major blood vessels or indistinct vascular boundaries, or imaging evidence of significant cavitary or necrotic lung tumors. 5.Major surgery (other than diagnostic or biopsy procedures) within 28 days before the first dose, or traumatic minor surgery (e.g., biopsy, bronchoscopy, thoracentesis) within 7 days before the first dose. 6.Arterial/venous thrombotic events within 6 months before randomization, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism. 7.Hemoptysis or coughing up >2.5 mL of blood per day within 1 month before randomization. History of hereditary or acquired bleeding disorders or coagulation dysfunction. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc. 8.Palliative radiotherapy completed within 7 days before the first dose. 9.Failure to recover from prior intervention toxicities and/or complications to = Grade 1 per NCI-CTCAE criteria. 10.Current participation in another clinical study, or time from the last dose of a prior clinical study to the first dose in this study being less than 4 weeks or 5 half-lives of the investigational drug (whichever is shorter). 11.Treatment with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within <5 half-lives before the first dose. 12.History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 13.Poorly controlled or severe cardiovascular diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA Class II-IV), myocardial infarction within 6 months before the first dose, or unstable angina or ventricular arrhythmia requiring treatment/intervention within 1 month before study treatment initiation. 14.History of non-infectious interstitial lung disease (ILD) or pneu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation; | — |
Countries
China
Contacts
Public ContactGuangyuan Lou
Zhejiang Cancer Hospital
Outcome results
None listed