Non-small cell lung cancer
Conditions
Interventions
Group 1:Sintilimab combined with Anlotinib
Group 2:Sintilimab
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent; 2. Male or female patients between the ages of 18-75 years; 3. The investigator believes that the subject is able to follow the study protocol; 4. At least one measurable lesion as a target lesion (according to RECIST 1.1); 5. According to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Staging, 8th Edition, TNM staging of lung cancer,histologically or cytologically confirmed locally advanced (stage IIIb), metastatic (stage IV) or recurrent non-squamous NSCLC patients; 6. Patients with locally advanced or metastatic NSCLC who have previously received chemotherapy with a platinum-based dual regimen; 7. ECOG PS 0-1 points; 8. The expected survival period is =3 months; 9. The main organ function meets the following criteria: (1)Blood routine test: Hemoglobin > 80g/L; Absolute neutrophil count (ANC) >1.5×10^9/L; Platelets >80×10^9/L; (2)biochemical tests: Serum total bilirubin <1.5 times the normal upper limit; ALT, AST < 2.5 times the normal upper limit,<5 times the normal upper limit (with liver metastases); Serum creatinine < 1.25 times the normal upper limit,Urinary routine examination of urine protein <2+, or 24h urine protein <1g;INR or PT=1.5 times ULN; 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 3 days prior to treatment and the results are negative and willing to use appropriate methods of contraception during the trial and 180 days after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 180 days after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1) Patients who have used anti-angiogenic therapy such as Anlotinib in first-line treatment; 2) Previous treatments have been given to anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or to another drug that stimulates or synergistically inhibits T-cell receptors (eg CTLA-4, OX-40, CD137); 3) Systemic systemic treatment of Chinese patent medicines or immunomodulatory drugs with anti-lung cancer indications within 2 weeks before the first administration or major surgical treatment within 3 weeks before administration; 4) Patients with uncontrolled high blood pressure; 5) Pulmonary radiation therapy of >30 Gy within 6 months prior to the first dose; 6) Completed palliative radiotherapy within 7 days prior to the first dose; 7) There is clinically uncontrollable pleural effusion/peritoneal effusion; 8) Clinical active diverticulitis, abdominal abscess, gastrointestinal obstruction; 9) Received a physical organ or a blood system transplant; 10) It is known that there is severe allergic reaction (=3 grade) to PD-1 mAb, Anlotinib and its active ingredients and/or excipients; 11) Active autoimmune diseases requiring systemic treatment within 2 years prior to the first dose; 12) Diagnosis of immunodeficiency or study of systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose, but allowing the use of a physiological dose of glucocorticoid (=10 mg/day of prednisone or Equivalent drug); 13) Before starting treatment has not fully recovered from the toxicity and/or complications caused by any intervention (ie, 50 mL/day); 24) Patients whose tumor has invaded an important blood vessel or who is judged by the investigator to have major bleeding during the follow-up study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;AEs;Time to response;Duration of Overall Response;Quality of life; | — |
Countries
China
Contacts
Public ContactZhao Wenhua
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed