Efficacy of Platinum-based Chemotherapy With or Without Immune Checkpoint Inhibitors in Patients With EGFR/ALK/ROS1 Sensitive Mutated NSCLC Who Progressed From Previous Tyrosine Kinase Inhibitors (TKI) Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
详细描述
The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
This study will be divided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included.
Cohort B for ALK fusion NSCLC, Patient with NGS identified ALK fusion NSCLC who failed from first line Alectinib/Lorlatinib/Ceritinib/Ensartinib/Brigatinib will be included. All the patients will be divided two group,3'ALK and 3'ALK with retention of 5'ALK.
Cohort C for ROS1 fusion NSCLC, Patient with NGS identified ROS1 fusion NSCLC who failed from first line Crizotinib/Entrectinib/Ensartinib/Brigatinib will be included.
The investigators will collect the safety and efficacy data for all the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed, Stage IV NSCLC.
- •EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.1.
排除标准
- •Cancer-Specific Exclusions:
- •Active or untreated central nervous system metastases.
- •Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- •General Medical Exclusions:
- •Pregnant or lactating women.
- •History of autoimmune disease.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •Positive test for human immunodeficiency virus.
- •Active hepatitis B or hepatitis C.
- •Severe infection within 4 weeks prior to randomization.
- •Significant cardiovascular disease.
- •Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
- •Exclusion Criteria Related to Medications:
- •Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.
研究组 & 干预措施
Arm A: EGFR mutant Group
EGFR mutant Group.
干预措施: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab (Drug)
Arm B: ALK fusion Group
ALK fusion Group.
干预措施: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab (Drug)
Cohort C: ROS1 fusion Group.
ROS1 fusion Group.
干预措施: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Time from first subject dose to study completion, or up to 36 month
To assess progression-free survival of patients treated with Immune Checkpoint Inhibitor, Bevacizumab in combination with Chemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause
次要结局
- Objective Response Rate (ORR)(Time from first dose to last dose, or up to 24 month)
- Overall survival (OS)(Time from first subject dose to study completion, or up to 36 month)
- Adverse events (AEs) according to CTCAE 5.0(From first dose until 28 days after the last dose, up to 24 month)
研究者
Yongchang Zhang
Head of Medical Oncology, Director of Early Clinical Trial Center
Hunan Province Tumor Hospital