NCT03924050已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Pemetrexed + Platinum Chemotherapy With or Without Toripalimab (JS001) in Advanced Non-small Cell Lung Cancer (NSCLC) Participants With TKI-resistant EGFR-mutated Tumors
Shanghai Junshi Bioscience Co., Ltd.2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2019年5月6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
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- OS
研究概览
简要总结
This is a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with chemotherapy in Advanced Non-small Cell Lung Cancer (NSCLC) Participants with TKI-resistant EGFR-mutated Tumors; and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population.
About 440 subjects with advanced non-small cell lung cancer with activated EGFR mutation will be 1:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group. The stratification will be based on the following factors:
The history of the previous lines of EGFR-TKI treament ( 1st or 2nd generation of TKI vs. 3rd generation of TKI vs. 1st or 2nd generation of TKI + 3rd generation of TKI) ; Disease stage (IIIB-C vs. IV);
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
- •Only the patients meeting all the following criteria can be eligible to participate in the trial:
- •Fully informed consent and signed ICF;
- •Age of 18-75 years;
- •Histologically and/or cytologically confirmed advanced or recurrent stage III B-C or IV (AJCC Version 8) NSCLC with TKI-resistant EGFR-mutated tumors, which also satisfy following conditions: Without T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.) treatment failure;If with T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.),participants are required to have osimertinib or other 3rd generation EGFR-TKI treatment failure prior to enrollment.Participants with osimertinib treatment failure as 1st line therapy (regardless of their EGFR T790M mutation status);Previous neoadjuvant/adjuvant chemotherapy is allowed, but the time interval between the last dose of chemotherapy and recurrence/metastasis must be at least 6 months.
- •With at least one measurable disease per RECIST 1.1;
- •Agree to provide formalin fixed tumor specimen after EGFR-TKI treatment failure or provide fresh biopsy tissue;
- •ECOG performance status of 0-1;
- •Life expectancy ≥ 3 months;
- •Good organ function;
- •Any adverse event resulting from prior treatment, surgery, or radiotherapy must return to grade 0 or 1 according to NCI-CTCAE v5.0, except for alopecia of any grade;
- •Willing and able to follow protocol visits, treatment plans, laboratory tests and other study procedures;
- •Women of childbearing potential must have negative serum pregnancy test within 3 days prior to the first dose of investigational product:
排除标准
- •Exclusion of tumor histology or cytology confirmed the presence of small cell lung cancer components, or squamous cell carcinoma components of more than 10%;
- •Combined with other driver mutations with known therapeutic drug, including but not limited to: ALK rearrangement, ROS1 mutation, BRAF600E mutation;
- •Previous systematic chemotherapy for advanced NSCLC;
- •Subjects with no measurable lesions;
- •Subjects with cancer meningitis and spinal cord compression;
- •Subjects with untreated central nervous system (CNS) tumor metastasis;
- •Subjects were previously treated with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 agent;
- •Subjects with any active, known or suspected autoimmune disease;
- •Subjects who are now participating in other clinical studies or the last dose of prior investigational drug was given in < 4 weeks (or 5 half-lives) from the first investigational product administration of this study;
- •Subjects who were expected to receive any other antitumor therapy (eg, other maintenance therapy for NSCLC, radiotherapy, and/or surgical excision);
- •Subjects who received major surgery within 4 weeks prior to enrollment or were not fully recovered from prior surgery;
- •Subjects with other malignancies requiring concurrent treatment;
- •Subjects with grade II or above myocardial ischemia or myocardial infarction, or subjects with arrhythmia with poor control;
- •Subjects with uncontrolled pleural/pericardial effusion, or with ascites requiring repeated drainage;
- •Subjects with uncontrolled tumor-related pain;
- •Subjects with severe allergic reactions to other monoclonal antibodies and subjects with severe allergic reactions to pemetrexed, platinum or its prophylaxis;
- •Subjects with psychological disorder, alcohol alcoholism, drug abuse or drug dependency
研究组 & 干预措施
Group TORIPALIMAB combined with standard chemotherapy
Experimental
干预措施: TORIPALIMAB INJECTION(JS001 ) (Drug)
Group Placebo combined with standard chemotherapy
Placebo Comparator
干预措施: TORIPALIMAB INJECTION(JS001 ) (Drug)
结局指标
主要结局
OS
时间窗: Approximately 5 years
Overall survival，It's suitable for all subjects.
次要结局
- PFS (Progression Free Survival) by investigator(Approximately 4 years)
- TTR (Time to Response)(Approximately 4 years)
- ORR (Objective Response Rate)(Approximately 4 years)
- DOR (Duration of Response)(Approximately 4 years)
- DCR (Disease of Response)(Approximately 4 years)
- Incidence of AEs/SAEs(Approximately 5 years)
研究者
研究点 (2)
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