a study of tqb2450 in subjects with stage iii non-small cell lung cancer(nsclc)

Conditions: Stage III Non-small-cell Lung Cancer

Summary: this study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase iii clinical trial to evaluate the efficacy and safety of tqb2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (stage iii) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.


Eligibility criteria:
inclusion criteria: 1. 18-75 years old ; eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 2. histologically or cytologically confirmed unresectable (stage iii) non-small cell lung cancer. 3. at least has one measurable lesion before radiotherapy. 4. at least has one type of platinum-containing chemotherapy, absence of progression after concurrent/sequential chemoradiotherapy. 5. adequate laboratory indicators. 6. no pregnant or breastfeeding women, and a negative pregnancy test. 7. understood and signed an informed consent form. exclusion criteria: 1. squamous cell carcinoma meets following conditions should be excluded: 1. cavernous lung cancer. 2. has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month before the first administration. 2. has received anti-angiogenic drugs or other pd-1 / pd-l1 / ctla-4 antibody therapy or other immunotherapy against pd-1 / pd-l1 / ctla-4. 3. severe hypersensitivity occurs after administration of other monoclonal antibodies. 4. diagnosed and/or treated additional malignancy within 5 years with the exception of cured basal cell carcinoma of skin ,carcinoma in situ of prostate,and carcinoma in situ of cervix. 5. pathologically confirmed mixed small cell and non-small cell lung cancer. 6. egfr gene mutations. 7. has any active autoimmune disease or history of autoimmune disease. 8. after the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated. 9. has ≥grade 2 pneumonia. 10. immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \&gt; 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration. 11. has multiple factors affecting oral medication. 12. has active bleeding or a persistent decrease in hemoglobin. 13. has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration. 2.has received anti-angiogenic drugs or other pd-1 / pd-l1 / ctla-4 antibody therapy or other immunotherapy against pd-1 / pd-l1 / ctla-4. 14. has unhealed wounds, fractures, active gastric and duodenal ulcers, positive continuous fecal occult blood, ulcerative colitis in the first 4 weeks before the first administration. 15. has received nmpa approved anti-tumor drugs or immunomodulatory drugs for systemic treatment within 2 weeks before the first administration. 16.has a history of a hematological system transplantation or organ transplantation. 17. has active diverticulitis、peritoneal abscess, intestinal obstruction. 18. has any serious and/or uncontrollable disease. 19. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.