NCT05246514进行中（未招募）2 期
An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment (DESTINY-Lung05)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 72
- 试验地点
- 28
- 主要终点
- ICR-assessed ORR (Objective Response Rate)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Pathologically documented metastatic non-squamous NSCLC.
- •Has relapsed from or is refractory to at least one-line of anticancer treatment.
- •Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
- •WHO or ECOG performance status of 0 or
- •Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.
- •LVEF ≥ 50% within 28 days before enrolment.
排除标准
- •Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
- •Corrected QT interval (QTcF) prolongation to > 470 ms (females) or > 450 ms (males), based on average of the screening triplicate 12-lead ECG.
- •History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
- •Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
研究组 & 干预措施
T-DXd arm
Experimental
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
ICR-assessed ORR (Objective Response Rate)
时间窗: At an average of approximately 14 months
Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.
次要结局
- Investigator-assessed ORR (Objective Response Rate)(An average of approximately 14 months)
- ICR-assessed and Investigator-assessed DoR (Duration of Response)(At an average of approximately 14 months)
- ICR-assessed and Investigator-assessed DCR (Disease Control Rate)(Approximately 6 weeks)
- ICR-assessed and Investigator-assessed PFS (Progression-free Survival)(An average of approximately 14 months)
- OS (Overall Survival)(An average of approximately 22 months)
- ICR-assessed CNS-PFS (Central Nervous System Progression-free Survival)(An average of approximately 14 months)
- Serum Concentrations of T-DXd(An average of approximately 14 months)
- Serum Concentrations of Total Anti-HER2 Antibody(An average of approximately 14 months)
- Serum Concentrations of DXd(An average of approximately 14 months)
研究者
研究点 (28)
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