jRCT2051240173招募中不适用
A Phase 3, Randomized, open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 expression >= 1%
Bristol-Myers Squibb0 个研究点目标入组 88 人开始时间: 2025年1月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression >= 1% as determined by a central laboratory
- •Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
- •Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of <= 1 at screening.
- •Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
排除标准
- •Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations.
- •Participants must not have untreated central nervous system (CNS) metastases.
- •Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- •Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization.
- •Participants must not have an active autoimmune disease.
- •Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids.
- •Participants must not have a history of myocarditis, regardless of etiology.
- •Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
结局指标
主要结局
-
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
次要结局
- OS in randomized participants with PD-L1 >= 1%
- PFS
- ORR
- DoR
- AEs
- SAEs
- IMAEs
- NSCLC-SAQ total score
研究者
相似试验
进行中（未招募）
1 期
CombinatiOn of NivolumAb plus Relatlimab in patients with Advanced or metastatic soft-tissue Sarcoma: a proof-of-concept randomized phase II studyAdvanced soft-tissue sarcomaMedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002332-81-FRInstitut Bergonié67
撤回
不适用
A Phase II Study of Nivolumab in Combination with Radiation Therapy as Definitive Treatment for Patients with Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.KCT0004049Samsung Medical Center26
进行中（未招募）
1 期
A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)Stage IV Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001195-35-ESBristol-Myers Squibb International Corporation504
进行中（未招募）
1 期
A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)Stage IV Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001195-35-FRBristol-Myers Squibb International Corporation504
已完成
2 期
A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)10038666NSCLClung cancerNL-OMON56032Bristol-Myers Squibb13