Non-Small Cell Lung Cancer
Conditions
Interventions
experimental group(one-arm):oral Anlotinib and intravenous inject Sintilimab according to the study protocol
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patients are between the ages of 18 and 75, regardless of gender. 2. Advanced(stage IIIB/IV) or recurrent non-squamous non-small cell lung cancer confirmed by histopathology. 3. There is at least one measurable lesion according to the RECIST 1.1 standard and the lesion has not received radiotherapy. 4. The patient has previously received standard first-line systemic therapy for advanced or recurrent non-squamous non-small cell lung cancer and the treatment has failed. 5. Provide detectable specimens (tissue or pleural effusion specimens) for PD-L1 expression detection and genotype testing*, patients with negative EGFR-sensitive mutations, ALK fusion, and ROS1 fusion gene test would be enrolled; or patients with positive test results but who have received relevant targeted drug treatment and have progressed. 6. The ECOG score is 0 to 1 and the expected survival time is more than 3 months. 7. Patients may have a history of brain/meningeal metastases, but must undergo topical treatment (surgery/radiotherapy) prior to the start of the study and be clinically stable for at least 1 month (allowing the use of corticosteroids before the first dose of the study drug, but they should have been stopped 2 weeks before the trail). 8. The level of organ function is basically normal (7 days before the first study drug). 9. Serum pregnancy test results should be negative within 7 days before the first dose of the test drug for women of childbearing age; males with fertility or women who are pregnant may use highly effective contraceptive methods throughout the trial (such as oral contraceptives, intrauterine Contraceptives, libido or barrier contraception combined with spermicide), and continued contraception for 12 months after the end of treatment. 10. Patients voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who had previously been treated with Anlotinib,Sintilimab or other VEGFR-TKI, anti-PD1/PD-L1/PD-L2. 2. Patients who have received any anti-tumor treatment within 4 weeks. 3. Patients who participated in or were participating in other drug/therapy clinical trials within 4 weeks prior to the first dose of the study drug. 4. There was a large surgery within 4 weeks before the first administration of study drug or has not recovered from the side effects of this operation, live vaccination, immunotherapy, and radiotherapy was performed within 2 weeks. 5. Patients with malignant tumors previously (non-melanoma skin cancer and the following carcinomas in situ can be enrolled to this study: bladder carcinoma in situ, gastric carcinoma in situ, colon cancer in situ, endometrial carcinoma in situ, cervical carcinoma in situ/dysplasia, melanoma,or breast carcinoma in situ) were excluded unless complete remission was achieved at least 2 years prior to enrollment and and no additional treatment was required. 6. Hematopoietic stimulating factors were received within 1 week prior to the first dose of the study drug, such as patients who are receiving granulocyte colony-stimulating factor (G-CSF) and erythropoietin should be excluded. 7. HIV antibody or Treponema pallidum antibody test results were positive. 8. Active hepatitis B or hepatitis C patients. 9. It is known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; those known to be allergic to ilotinib and any of its excipients. 10. A large amount of pleural or ascites with clinical symptoms and requiring symptomatic treatment. 11. Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active tuberculosis. 12. Patients who have any clinical problems beyond control. 13. Have received allogeneic hematopoietic stem cell transplantation or organ transplantation. 14. A person with a history of psychotropic substance abuse who is unable to quit or has a history of mental disorders. 15. Patients who need to use the following drugs within 14 days prior to the first dose or during treatment: a strong inhibitor of CYP3A4 or a strong inducer; warfarin or any other coumarin derivative anticoagulant. 16. Patients who have a variety of factors affecting oral medications (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.). 17. Patients with signs or history of hemorrhage, regardless of severity; patients with any bleeding or bleeding episodes >= CTCAE 3 within 4 weeks prior to the first dose; or unhealed wounds, ulcers or fractures. 18. The investigator judges that it may increase the risk associated with participating in the study, or other severe, acute or chronic medical illness or laboratory abnormalities that may interfere with the interpretation of the findings. 19. The investigator judged poor adherence or other conditions that made it unsuitable for patients who participated in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS;safety; | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Outcome results
None listed