NCT06617416招募中3 期
A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy
Akeso1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2024年11月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) assessed by INV
研究概览
简要总结
This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must sign the written informed consent form (ICF) voluntarily.
- •Age ≥18 years.
- •Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
- •Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
- •Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
- •Chemotherapy regimens should be in accordance with current clinical guidelines.
- •Consolidation chemotherapy is not allowed after radiotherapy.
- •Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
- •No disease progression after concurrent or sequential chemoradiotherapy.
- •ECOG performance status score of 0-
- •Expected survival of over 3 months.
- •Adequate organ and bone marrow function.
排除标准
- •The histopathology contains any component of small cell lung cancer.
- •Currently participating in another interventional clinical study.
- •Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
- •Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
- •Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
- •Tumor invades important vessels or organs.
- •Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
- •Presence of interstitial lung disease that requires treatment.
- •Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
- •Experienced severe infection within 4 weeks prior to the first dose.
- •Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
- •Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
- •Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
研究组 & 干预措施
AK104 group
Experimental
AK104 Q3W
干预措施: Cadonilimab (AK104) (Drug)
Sugemalimab group
Active Comparator
Sugemalimab 1200mg Q3W
干预措施: Sugemalimab (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by INV
时间窗: 3 years
PFS is defined as the time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
次要结局
- OS(5 years)
- 6-month PFS rate assessed by INV(3 years)
- AEs(3 years)
研究者
研究点 (1)
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