A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group
研究概览
简要总结
This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.
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 stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology
- •Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)
- •No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease
- •Participants must have biomarker test results available for randomization
- •ECOG Performance Status of ≤ 1
- •Measurable disease by CT or MRI per RECIST 1.1 criteria
排除标准
- •Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements
- •Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- •Participants with an active, known or suspected autoimmune disease [Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]
- •Participants with untreated CNS metastases are excluded [Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment]
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Arm A
BMS-986205 and Nivolumab administered in combination
干预措施: BMS-986205 (Drug)
Arm A
BMS-986205 and Nivolumab administered in combination
干预措施: Nivolumab (Biological)
Arm B
BMS-986205 and Nivolumab administered in combination with chemotherapy
干预措施: BMS-986205 (Drug)
Arm C
Chemotherapy administered alone
干预措施: Chemotherapy (Drug)
Arm B
BMS-986205 and Nivolumab administered in combination with chemotherapy
干预措施: Nivolumab (Biological)
Arm B
BMS-986205 and Nivolumab administered in combination with chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group
时间窗: 24 months
Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first
时间窗: 34 months
次要结局
- Number of treatment-related adverse events (AE)(Approximately 5 years)
- Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause(Approximately 5 years)
- Number of treatment-related serious adverse events(Approximately 5 years)