NCT05922345招募中3 期
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 518
- 试验地点
- 5
- 主要终点
- Overall survival (OS)
研究概览
简要总结
To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.
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
- •The subjects voluntarily joined the study, signed an informed consent form, and had good compliance
- •Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline;
- •Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy;
- •Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC;
- •Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation;
- •Confirmed to have at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours（ RECIST 1.1） standard;
- •Adequate major organ function;
排除标准
- •Patients who Have been diagnosed or currently had other malignant tumors;
- •Presence of epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations;
- •Factors affecting oral drugs;
- •Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment;
- •Hyperactive/venous thrombotic events within 6 months;
- •Subjects with any severe and/or uncontrolled disease;
- •Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs);
- •According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;
研究组 & 干预措施
TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules
Experimental
TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle.
干预措施: TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules (Drug)
TQB2450 placebo + docetaxel injection + AL2846 placebo
Active Comparator
TQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle.
干预措施: TQB2450 placebo, docetaxel injection, AL2846 matching placebo (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From randomization to the time of death from any cause, assessed up to 36 months.
The time from randomization to the date of death from any cause.
次要结局
- Progression-free survival (PFS) by investigator assessment(From the date of randomization to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months.)
- Objective response rate (ORR)(Time from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.)
- Disease Control Rate (DCR)(Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.)
- Duration of response (DOR)(From the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first, assessed up to 36 months.)
- 12-month survival rate (12-month OS rate)(Baseline up to 12-month)
- Health Questionnaire Form(During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.)
- Effects on subjects' health-related quality of life(During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.)
- Patients with abnormal laboratory inspection indicators(From signing the informed consent form to the 30 days after the last dose.)
- Adverse event rate(From signing the informed consent form to the 30 days after the last dose.)
- Occurrence of anti-drug antibody (ADA)(Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.)
- Occurrence of neutralizing antibody (Nab)(Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.)
- Peak Concentration (Cmax)(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
- Trough concentration (Cmin)(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
- Peak time(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
- Area under the drug time curve (AUC)(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
- Clearance(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
- Apparent volume of distribution (Vd)(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
- The elimination half-life (t1/2)(60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.)
研究者
研究点 (5)
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