A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 36
- 主要终点
- Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed unresectable (Stage III) Non-Small Cell Lung Cancer.
- •At least has one measurable lesion before radiotherapy.
- •At least has one type of platinum-containing chemotherapy, Absence of progression after concurrent/sequential chemoradiotherapy.
- •Adequate laboratory indicators.
- •No pregnant or breastfeeding women, and a negative pregnancy test.
- •Understood and signed an informed consent form.
排除标准
- •Squamous cell carcinoma meets following conditions should be excluded:
- •Cavernous lung cancer.
- •Has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month before the first administration.
- •Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-
- •Severe hypersensitivity occurs after administration of other monoclonal antibodies.
- •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.
- •Pathologically confirmed mixed small cell and non-small cell lung cancer.
- •EGFR gene mutations.
- •Has any active autoimmune disease or history of autoimmune disease.
- •After the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated.
- •Has ≥grade 2 pneumonia.
- •Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.
- •Has multiple factors affecting oral medication.
- •Has active bleeding or a persistent decrease in hemoglobin.
- •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-
- •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.
- •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.
- •Has active diverticulitis、peritoneal abscess, intestinal obstruction.
- •Has any serious and/or uncontrollable disease.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB2450+Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib (Drug)
TQB2450+Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: TQB2450 (Drug)
TQB2450+Anlotinib(blank)
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: TQB2450 (Drug)
TQB2450+Anlotinib(blank)
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib(blank) (Drug)
TQB2450(blank)+Anlotinib(blank)
TQB2450 0 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: TQB2450(blank) (Drug)
TQB2450(blank)+Anlotinib(blank)
TQB2450 0 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib(blank) (Drug)
结局指标
主要结局
Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
时间窗: up to 33 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
次要结局
- Overall survival (OS)(up to 5 years)
- Overall response rate (ORR)(up to 33 months)
- PFS evaluated by Investigator(up to 33 months)
- Disease control rate（DCR）(up to 33 months)
- Duration of response（DOR）(up to 33 months)
- Biomarkers, such as PD-L1 expression, etc.(up to 33 months)
- Immunogenicity, such as the incidence of ADA(on day 1, 42, 105, 189 and 90 days after the last administration.)
- PFS rate at month 6(up to 6 months)
- PFS rate at month 12(up to 12 months)