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;
Parallel
TQB2450+Anlotinib
DrugTQB2450 injection test group, 1200 mg/time, strength: 600mg/20 mL, intravenous drip, day 1, every 3 weeks. Anlotinib hydrochloride capsules: 8 mg/time, strength: 10mg/capsule, 8mg/capsule, 6mg/capsule., 1 time a day (QD), continuous use for 2 weeks and stop for 1 week. TQB2450 Injection Placebo (control group): 0 mg/time, strength: 0mg/20 mL, Intravenous Drip, Day 1, every 3 weeks. Anlotinib hydrochloride capsule placebo: 0 mg/time, strength: 0mg/capsule, 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.
TQB2450 placebo + Anlotinib placebo
DrugNo drug substance is contained
Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC)
Random to the time of disease progression or death.
Progression-free survival (PFS) evaluated by researcher
Random to the time of disease progression or death.
Overall survival (OS)
Time from random to death.
Objective mitigation rate (ORR)
The proportion of patients whose tumor volume shrinks to the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete remission (CR) and partial remission (PR).
Remission duration (DOR)
The period when the first judgment is complete or partial remission until it is found to be the progress of the disease.
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