Non-small cell lung cancer
Conditions
Interventions
Case series:Sintilimab combined with Docetaxel
Sponsors
Shandong Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent; 2. Age between 18-75 years; 3. Pathological/cytological confirmed non-small cell lung cancer; 4. Local advanced, metastatic or recurrent NSCLC patients (UICC/AJCC, 8th Edition)disease progression or after or during or intolerant to first platinum based chemotherapy; 5. At least one measurable lesion (RECIST 1.1); 6. ECOG PS 0-1; 7. Expected survival >=12 weeks; 8. Men and women of childbearing age must be willing to use appropriate methods of contraception during the trial and 24 weeks after the last administration of study drug. 9. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Small cell cancer and non-small cell mixed lung cancer 2. Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or taxanes 3. Received any of the following treatment: 1) any systemic anti-tumor therapy within 3 weeks before enrollment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal therapy with anti-tumor indications), etc.; 2) any investigational medication within 4 weeks before enrollment; 3) immunosuppressive drugs (systemic glucocorticoid over 10 mg/ d prednisone or its equivalent) within 4 weeks before enrollment; 4) live attenuated vaccine within 4 weeks before enrollment (or planned to receive live attenuated vaccine during the study); 5) major surgery (such as thoracotomy, or laparotomy) within 4 weeks before enrollment, or any unhealed surgical wound, ulcer, or fracture 4. Adverse effects of any previous anti-tumor treatment did not return to CTCAE=1 (excluding hair loss and laboratory tests of no clinical significance). 5. Any immunodeficiency disease or medical history; 6. History of organ transplantation 7. Allergic to sintilimab or docetaxel 8. >30Gy thoracic radiotherapy within 6 weeks before treatment or palliative radiotherapy within 7 days before randomization 9. Patients with symptoms of brain/meningeal metastasis. 10. Interstitial lung disease 11. Contraindicated infusion of superior vena cava syndrome. 12. Clinically uncontrollable pleural effusion/peritoneal effusion. 13. Any serious or uncontrolled systemic disease. 14. Other acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that may result in increased risk associated with study participation or study drug administration. 15. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DOR;SAFETY; | — |
Countries
China
Contacts
Public ContactZhehai Wang
Shandong Provincial Cancer Hospital
Outcome results
None listed