A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 122
- 主要终点
- Overall Survival (OS), Groups A-C Only
研究概览
简要总结
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
详细描述
Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)
**Please note that the study is no longer enrolling patients for Groups A, B, C, and E.
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
- 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
- •Histologically confirmed locally advanced or stage IV NSCLC
- •Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- •Tumor tissue sections must be available for biomarker evaluation
排除标准
- •Untreated or active/progressing Central Nervous system (CNS) metastases
- •Active, known or suspected autoimmune disease
- •Known history of testing positive for HIV or AIDS
- •Active or chronic infection of hepatitis B virus or hepatitis C
研究组 & 干预措施
Group A SOC maintenance therapy
Bevacizumab specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Bevacizumab (Drug)
Group A Nivolumab
Opdivo specified dose on specified days
干预措施: Nivolumab (Drug)
Group A Nivolumab + SOC maintenance therapy
Opdivo/Bevacizumab specified dose on specified days
Opdivo/Pemetrexed specified dose on specified days
干预措施: Nivolumab (Drug)
Group A Nivolumab + SOC maintenance therapy
Opdivo/Bevacizumab specified dose on specified days
Opdivo/Pemetrexed specified dose on specified days
干预措施: Bevacizumab (Drug)
Group A Nivolumab + SOC maintenance therapy
Opdivo/Bevacizumab specified dose on specified days
Opdivo/Pemetrexed specified dose on specified days
干预措施: Pemetrexed (Drug)
Group A SOC maintenance therapy
Bevacizumab specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Pemetrexed (Drug)
Group B Nivolumab
Opdivo specified dose on specified days
干预措施: Nivolumab (Drug)
Group B Best supportive care
Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
干预措施: Best Supportive Care (Other)
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Pemetrexed (Drug)
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: nab-Paclitaxel (Drug)
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Paclitaxel (Drug)
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Docetaxel (Drug)
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Gemcitabine (Drug)
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
干预措施: Carboplatin (Drug)
Group C Nivolumb
Opdivo specified dose on specified days
干预措施: Nivolumab (Drug)
Group D Erlotinib
Erlotinib specified dose on specified days
干预措施: Erlotinib (Drug)
Group D Nivolumab + Erlotinib
Opdivo/Erlotnib specified dose on specified days
干预措施: Nivolumab (Drug)
Group D Nivolumab + Erlotinib
Opdivo/Erlotnib specified dose on specified days
干预措施: Erlotinib (Drug)
Group E Nivolumab + Crizotinib
Opdivo/Crizotinib specified dose on specified days
干预措施: Nivolumab (Drug)
Group E Nivolumab + Crizotinib
Opdivo/Crizotinib specified dose on specified days
干预措施: Crizotinib (Drug)
结局指标
主要结局
Overall Survival (OS), Groups A-C Only
时间窗: up to approximately 60 months
Overall survival (OS) is defined as the time from randomization to the date of death.
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
时间窗: up to approximately 60 months
Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
Progression-Free Survival (PFS), Groups A-D Only
时间窗: up to approximately 48 months
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
次要结局
- Progression-Free Survival (PFS), Group E Only(up to approximately 48 months)
- Duration of Response (DOR), Groups A-D Only(up to approximately 48 months)
- Objective Response Rate (ORR), Groups A-E(up to approximately 48 months)
- Overall Survival (OS), Group D Only(up to approximately 60 months)