QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.
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
- Double (Participant, Investigator)
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 voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
- •Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
- •Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.
- •Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
- •Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.
排除标准
- •Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.
- •Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
- •Cardiovascular and cerebrovascular diseases with clinical significance.
- •Gastrointestinal disease of clinical significance.
- •Clinically significant lung damage.
- •Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
- •Active uncontrolled hepatitis B or active hepatitis C.
- •Administer a live vaccine within 30 days prior to the first dose of study treatment.
- •Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)
- •Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc.
- •History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.
研究组 & 干预措施
QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: QL1706 injection (Drug)
QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Vinorelbine Tartrate (Drug)
QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Paclitaxel (Drug)
QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Cisplatin (Drug)
QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Carboplatin (Drug)
QL1706 plus Platinum-based chemotherapy
QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Pemetrexed (Drug)
Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Vinorelbine Tartrate (Drug)
Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Paclitaxel (Drug)
Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Cisplatin (Drug)
Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Carboplatin (Drug)
Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Pemetrexed (Drug)
Placebo plus Platinum-based chemotherapy
Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy
干预措施: Placebo (Drug)
结局指标
主要结局
Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
时间窗: Up to approximately 84 months
DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis.
Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.
时间窗: Up to approximately 84 months
次要结局
- DFS Within Selected Populations(Up to approximately 108 months)
- Overall Survival (OS)(Up to approximately 108 months)
- Percentage of Participants Who are Survival at Year 4(Year 4)
- Percentage of Participants Who are Disease-Free at Year 5(Year 5)
- Percentage of Participants Who are Disease-Free at Year 3(Year 3)
- Percentage of Participants with Adverse Events and Serious Adverse Events(Up to approximately 108 months)