NCT06525246已完成1 期
ONO-7475-03: ONO-7475 Phase I Study An Open-label, Uncontrolled Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 13
- 主要终点
- Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
研究概览
简要总结
This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
- •Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
- •Patient has an ECOG performance status of 0-1
排除标准
- •Patients with severe complication
- •Patients with multiple primary cancers
研究组 & 干预措施
ONO-7475+Osimertinib
Experimental
干预措施: ONO-7475 (Drug)
ONO-7475+Osimertinib
Experimental
干预措施: Osimertinib Mesylate (Drug)
结局指标
主要结局
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
时间窗: 28 days
Adverse event (AE)
时间窗: Up to 28 days after the last dose
次要结局
- Pharmacokinetics (Cmax)(Up to 57 Days)
- Pharmacokinetics (Tmax)(Up to 57 Days)
- Pharmacokinetics (AUC)(Up to 57 Days)
- Disease Control Rate (DCR)(Through study completion, an average of 2 year)
- Progression-Free Survival (PFS)(Through study completion, an average of 2 year)
- Pharmacokinetics (Ctrough)(Up to 57 Days)
- Objective Response Rate (ORR)(Through study completion, an average of 2 year)
- Overall Survival (OS)(Through study completion, an average of 3 year)
- Duration of Response (DOR)(Through study completion, an average of 2 year)
- Time to Response (TTR)(Through study completion, an average of 2 year)
- Best Overall Response (BOR)(Through study completion, an average of 2 year)
- Percent change in the sum diameters of the target lesions(Through study completion, an average of 2 year)
- Maximum percent change in the sum diameters of the target lesions(Through study completion, an average of 2 year)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
1 期
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsNCT03730337Ono Pharmaceutical Co. Ltd24
进行中（未招募）
1 期
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal CancerUnresectable Colorectal CancerNCT06540261Ono Pharmaceutical Co. Ltd65
终止
1 期
A Study of ONO-7475 in Patients With Acute LeukemiasMyelodysplastic SyndromesAcute LeukemiaNCT03176277Ono Pharmaceutical Co. Ltd42
已完成
2 期
Study of ONO-8577 in Patients With Overactive BladderOveractive BladderNCT03106623Ono Pharmaceutical Co. Ltd207
终止
1 期
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid TumorsSolid TumorNCT06535009Ono Pharmaceutical Co. Ltd25