A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 925
- 试验地点
- 179
- 主要终点
- Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)
研究概览
简要总结
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).
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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
- •Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
排除标准
- •Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
- •Active infection requiring systemic therapy within 14 days prior to randomization
- •History of organ or tissue transplant that requires systemic use of immune suppressive agents
- •Prior thoracic radiotherapy
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A: nivolumab + CCRT + ipilimumab
Concurrent chemoradiotherapy (CCRT)
干预措施: nivolumab (Biological)
Arm A: nivolumab + CCRT + ipilimumab
Concurrent chemoradiotherapy (CCRT)
干预措施: ipilimumab (Biological)
Arm B: nivolumab + CCRT
Concurrent chemoradiotherapy (CCRT)
干预措施: nivolumab (Biological)
Arm C: CCRT + durvalumab
Concurrent chemoradiotherapy (CCRT)
干预措施: durvalumab (Biological)
结局指标
主要结局
Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)
时间窗: From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
次要结局
- Overall Survival (OS)(From randomization untill death (up to approximately 61 months))
- Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Objective Response Rate (ORR) by BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Duration of Response (DoR) by RECIST 1.1 Per BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Time to Response (TTR) by RECIST 1.1 Per BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
- Time to Death or Distant Metastases (TDDM)(From randomization until metastases or death, whichever occurs first (up to approximately 61 months))
- Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs(From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months))
- Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48(Baseline (Day 1) and Week 48)