2025-520792-67-00招募中3 期
A phase III trial of a De-escalated Immune-strategy During first-line treAtment in patients with metastatic non-small Cell lung cancer (NSCLC): DIDaC
Leids Universitair Medisch Centrum (LUMC)6 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年9月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Time to disease progression as measured by RECIST 1.1 or death due to any cause in each arm, where each patient is followed for progression for a maximum of 18 months after randomization.
研究概览
简要总结
To evaluate the efficacy of shorter duration of standard of care treatment ([chemo]immunotherapy) for patients with metastatic NSCLC
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Advanced, metastatic non-small cell lung cancer UICC stage IV
- •Having received first line immunotherapy or first line (chemo)immunotherapy for 6 months ±2 weeks
- •Response or stable disease according to RECIST 1.1 as determined by imaging no older than 3 weeks at moment of randomization
- •Signed and dated informed consent.
- •ECOG PS 0-2 and fit and willing to continue treatment with first line (chemo-)immunotherapy as deemed by the treating physician
排除标准
- •Other systemic anti-cancer treatment for the disease under study other than the first line (chemo-)immunotherapy
- •Any contra-indication (as per label) for treatment with immune checkpoint inhibitors
结局指标
主要结局
Time to disease progression as measured by RECIST 1.1 or death due to any cause in each arm, where each patient is followed for progression for a maximum of 18 months after randomization.
Time to disease progression as measured by RECIST 1.1 or death due to any cause in each arm, where each patient is followed for progression for a maximum of 18 months after randomization.
次要结局
- Number of patients alive at 18 months after randomization of the last patient in each arm.
- The number and type of adverse events classified by CTCAE 5.0 grading in each arm.
- EQ-5D-5L, QLQ-C30 and QLQ-LC19 questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation.
- iMC, EQ-5D-5L questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation.
研究者
Egbert Smit
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (6)
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