Squamous non-small cell lung cancer
Conditions
Interventions
single-arm:Anlotinib (12mg, d1-14, PO, Q3W) combined with Sintilimab (200mg, d1, IV, Q3W)
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All subjects were required to sign the informed consent form (ICF) before starting the study 2. Patients over 18 years old and less than 75 years old; 3. According to the International Association for the study of lung cancer and the United States Joint Committee on cancer classification, 8th Edition, TNM of lung cancer Stage, histologically or cytologically confirmed locally advanced (iiib-iiic), metastatic or recurrent (stage IV) squamous non-small cell lung cancer (TNM stage 8 of the International Association for the study of lung cancer and the United States Joint Committee on cancer classification, 8th Edition); the following three conditions can be used: (1) If disease progression (RECIST v1.1) occurs during or after first-line platinum containing chemotherapy (including maintenance chemotherapy), it is allowed to stop, reduce or replace one of the drugs in the first-line treatment; (2) The toxicity of the first-line platinum containing chemotherapy regimen (receiving at least one complete cycle of treatment) was not tolerated, and other systemic treatment regimens must be changed; (3) After radical resection, the disease relapsed or progressed within 6 months after platinum adjuvant chemotherapy; 4. At least one measurable lesion was confirmed according to RECIST 1.1; 5. Patients with ECoG PS 0 ~ 1 score; 6. Patients with an estimated survival time of more than 12 weeks; 7. Male subjects and women of childbearing age were required to start the first dose of the study drug to 24 hours after the last study drug; Patients who had contraception during the week; 8. Organ function meets the following requirements: (1) Blood routine examination: white blood cell (WBC) >= 3.0 x 10^9 / L; absolute neutrophil count (ANC) >=1.5 x 10^9 / L; platelet (PLT) >= 100 x 10^9 / L; hemoglobin content (Hgb) >= 9.0 g/dl; (2) Liver function: aspartate aminotransferase (AST) =3 g/dl; (3) Renal function: serum creatinine = 60ml / minute (using Cockcroft / Gault formula); urinary protein (Upro) less than 2 +, or 24-hour urinary protein quantitative < 1g; (4) Coagulation function: international normalized ratio (INR) <= 1.5 x ULN, activated partial thromboplastin time (APTT) <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with non-small cell lung cancer and non-small cell lung cancer (including lung cancer with mixed small cell carcinoma and non-small cell cancer in the center). 2. Patients who have received anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies or anti angiogenesis drugs in the past. 3. Patients with multiple factors affecting oral medication (such as inability to swallow, after gastrointestinal resection, chronic diarrhea, and intestinal obstruction). 4. Type IV cavitary squamous cell carcinoma or patients with bleeding symptoms or bleeding tendency assessed by researchers. 5. Received the following treatment: (1) He received systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indication) within 3 weeks before randomization; (2) They received any research drug treatment within 4 weeks before randomization; (3) Over dose of immunosuppressive drugs (systemic glucocorticoid more than 10 mg / day, prednisone or its equivalent dose) was received within 4 weeks before randomization; (4) Have received live attenuated vaccine within 4 weeks before randomization (or plan to receive live attenuated vaccine during the study period); (5) Major surgery (such as open surgery, thoracotomy or laparotomy) or unhealed surgical wound, ulcer or fracture within 4 weeks before randomization. No clinical significance was found in patients with grade 1 or less of anti-tumor treatment. Patients with known autoimmune diseases, such as vititis, purulent nephritis, or other known diseases, such as vititis, purulent nephritis, or other diseases that can be treated with insulin only Patients with well controlled type 1 diabetes can also be included. 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 9. Patients who are allergic to any ingredient of sindilimab or anlotinib preparation. 10. Subjects who received more than 30 Gy of chest radiation therapy within 6 months before randomization or received 30 Gy or less palliative radiotherapy within 7 days before randomization (palliative radiotherapy for bone or intracranial lesions is allowed). 11. Patients with symptomatic brain / meningeal metastases. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases can participate in this study as long as they meet the following criteria: measurable lesions outside the central nervous system, no history of intracranial hemorrhage, and currently no glucocorticoid treatment is required. 12. Patients with clinically uncontrollable third space effusion, such as pleural effusion and ascites that cannot be controlled by drainage or other methods before enrollment. 13. Patients with other serious uncontrolled diseases, including but not limited to: (1) Severe infection in active stage or poorly controlled; (2) HIV infection (HIV antibody positive); (3) Patients with untreated acute or chronic active hepatitis B (HBV DNA > 1 x 10^3 copies / ml or > 200iu / ml) or acute or chronic active hepatitis C (HCV antibody positive); (4) Active pulmonary tuberculosis, etc; (5) Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; (6) Uncontrolled arterial hypertension (SBP >= 160mmhg or DBP >= 100mmhg); (7) Any arterial thrombosis, embolism or ischemia, such as myocardial i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (0S);Overall response rate (ORR);Duration of response (DOR);Safety;Correlation between tumor immune markers and changes in immune-related gene expression induced by induction therapy and efficacy; | — |
Countries
China
Contacts
Public ContactJunmin Wei
Qilu Hospital of Shandong University
Outcome results
None listed