A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Parallel Assignment, No masking
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 130age old under（—）
- 性别
- All
入选标准
- •Aged at least 18 years.
- •Histologically or cytologically documented Stage IV NSCLC.
- •Confirmed tumor PD-L1 status prior to randomization.
- •Patients must have tumors that lack activating EGFR mutations and ALK fusions.
- •No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
- •World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.
排除标准
- •Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
- •Active or prior documented autoimmune or inflammatory disorders.
- •Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
- •Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
结局指标
主要结局
Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
时间窗: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
PFS (per RECIST version 1.1 [RECIST 1.1] using Blinded Independent Central Review [BICR] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity).
Overall Survival (OS); D + SoC Compared With SoC Alone
时间窗: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity).
次要结局
未报告次要终点