lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Advanced (IV phase)non squamous NSCLC confirmed by pathology, with measurable lesions (tumour lesions >= 10mm in longest diameter, malignant lymph nodes >= 15mm in short axis, scanning layer = 90g/L ( no blood transfusion in 2 weeks); 2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; 4) Bilirubin 45 ml/min(Cockcroft-Gault Formula); 8) cholesterol = LLN by Color Doppler Ultrasonography. 7. Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last dose of test article; 8. Ability to understand and willingness to sign a written informed consent. Good compliance with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer; 2. EGFR mutation or ALK fusion positive subjects; 3. without measurable lesions. 4. with cancerous meningitis, spinal cord compression, etc.; 5. with untreated central nervous system (CNS) tumor metastases. If the subject's CNS tumor metastasis is limited to the supratentorial and/or cerebellum and has received adequate treatment, such as clinical stability (imaging testing, enhanced MRI or CT is preferred) has been maintained for at least 4 weeks, and the subject's nervous system If the clinical symptoms can be restored to NCI-CTC AE <=1 degree at least 2 weeks before the first medication, you can participate in the study. In addition, if subjects use corticosteroids to treat related clinical symptoms, they should receive a stable or gradually decreasing dose of prednisone (or equivalent) of <=10 mg/day for at least 2 weeks before participating in the study, otherwise they cannot be included in the group; 6. Subjects who can be surgically removed or treated with radical radiotherapy; 7. Subjects who have received PD-1/PD-L antibody or VEGF inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall-survival;objective response rate; | — |
Countries
China
Contacts
Shanghai Pulmonary Hospital