This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.
The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
Age: 18~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance Status score: 0-1 points; expected survival of more than 6 months; weight > 40 kg;
Pathologically confirmed patients with limited stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG) stage);
There was no evidence of metastatic disease by diagnostic quality enhanced CT of the neck, chest, abdomen, and pelvic cavity, and craniocerebral plain scan plus enhanced MRI (PET-CT is recommended before chemoradiotherapy. Bone scan should be performed if PET-CT is not performed before chemoradiotherapy. PET-CT must be performed during the screening period after chemoradiotherapy to rule out metastasis.);
Tumor disease and history
Present or present with other malignant tumors within 3 years. The following two conditions can be included: 5 consecutive years of disease-free survival (DFS) without any treatment for other malignancies; Cured of thyroid cancer, Cervical carcinoma in situ, Non-melanoma skin cancer and superficial bladder tumors【Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basal membrane)】;
Complex small cell lung cancer confirmed by histopathology or cytopathology;
Subjects with known central nervous system metastatic and/or cancerous meningitis;
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Lead sponsor