Non-small cell lung cancer
Conditions
Interventions
single arm:Anlotinib plus TQB2450
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Man or woman between 18-75 years old; 2. Histologically or cytologically confirmed diagnosis of Stage IIIBIIICIV NSCLC; 3. Investigator-determined treatment failure with an EGFR TKI therapy: a) Participants previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation; b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib /gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment; c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status; 4. Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology; 5. Life expectancy of at least 3 months ECOG PS 0-1; 6. AEs caused by other treatments was restored (NCI-CTCAE version 4.0 grading < grade 1); 7. Adequate organ function; 8. Women of childbearing age should agree to the usage of contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study, the serum or urine test is negative within 7 days prior to the study, and should be non-lactating patients. Males should agree to the usage of contraceptives during the study and within 6 months after the end of the study period; 9. Subjects volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Other malignancies within 5 years or simultaneously, cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor except [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltration basement membrane)]; 2. Central type, with empty lung squamous cell carcinoma or non-small cell lung cancer; 3. Received prior systemic cytotoxic chemotherapy; 4. Received prior anti-programmed cell death (PD)-1, anti-PD-L1 or another immunotherapy against PD-1/PD-L1; 5. Severe hypersensitivity is known to occur after administration of other monoclonal antibodies; 6. Anaphylaxis to Anlotinib Hydrochloride or excipients in test drugs; 7. Has any active autoimmune disease or history of autoimmune disease, such as autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis, asthma patients who need bronchiectasis for medical intervention; Subjects with the vitiligo without systemic treatment, psoriasis, alopecia, well-controlled type I diabetes mellitus, hypothyroidism stable on hormone replacement will not be excluded from this study; 8. Has clinical significance of thyroid dysfunctions within 6 months prior to enrollment, and even though medical therapy, thyroid function can not return to normal or no clinical significance; 9. Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc; 10. Brain metastasis patients with symptoms or symptoms control time less than 14 days; 11. Has any of the following severe acute complications: a) Unstable angina and/or congestive heart failure or vascular disease requiring hospitalization within 12 months, or other cardiac impairments determined by the investigator, which may affect the evaluation of drug safety; Myocardial infarction or ischemia with ST elevation >= 2 mm indicated by electrocardiogram (ECG); b) Has pulmonary infections and/or acute bacterial or fungal infections requiring intravenous antibiotic therapy; c) Has clinical jaundice caused by liver dysfunction; 12. Major surgical treatment, incision biopsy or significant trauma were performed within 28 days before enrollment; 13. Virological test indicates one of the following items before enrollment: a) HBsAg positive and HBV DNA >= 1 x 10^3 copies/mL; b) Anti-HCV positive and HCV virus titer detection value exceeds the upper limit of normal value; c) HIV positive; 14. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression; 15. Has participation in an anti-tumor clinical trial within 28 days prior to the first administration; 16. Imaging shows that the tumor has violated important vascular or the researchers determine that the tumor is likely to invade critical blood vessels by fatal bleeding during the follow-up study; 17. Irrespective of severity, patients show any signs of bleeding or medical history; in the first 4 weeks before the group, patients have any bleeding or bleeding events ( >= CTCAE 3) with non-healing wounds, ulcers, or fractures; 18. Hemoptysis (defined as coughing out or spitting out >= 1 teaspoon of blood or small blood clots or hemoptysis without sputum) within 28 days before enrollment, not including bloody sputum; 19. Persons with a history of psychotropic substance abuse who are unable to give up o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;ORR;DCR;1 year overall survival rate;1 year progression-free survival rate; | — |
Countries
China
Contacts
Public ContactFeng Jifeng
Jiangsu Cancer Hospital
Outcome results
None listed