NCT02917993已完成1 期
An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic 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
- 59
- 试验地点
- 55
- 主要终点
- Phase 1: Frequency, severity, and duration of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (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
- •18 years of age or older at screening; outside the U.S. and European Union, an older limit could apply depending on local regulation (eg, 19 years and older for South Korea and 20 years and older for Taiwan).
- •Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.
- •Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample. If a tissue sample is not available, then EGFR mutation status may be determined from circulating tumor DNA obtained from a blood sample using a validated or approved test kit.
- •Phase 1: Subjects must have previously received and progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). Additional lines of systemic therapy including investigational agents for locally advanced or metastatic NSCLC are allowed.
- •Phase 2: Subjects must not have received more than 1 prior line of therapy for locally advanced or metastatic NSCLC. First-line treatment must include an EGFR TKI, and subjects must have documented disease progression during or following treatment. Subjects with disease that progressed more than 6 months after completion of neoadjuvant/adjuvant chemotherapy or chemoradiation therapy are eligible if they received an EGFR TKI as first-line treatment for advanced NSCLC.
- •Subjects must have evidence of a T790M mutation in tumor tissue or plasma obtained after disease progression during or after treatment with an EGFR TKI. T790M mutation status from a local laboratory is acceptable; however, a tumor tissue sample or plasma sample suitable for centralized T790M mutation analysis must be available.
- •Radiographically measurable or evaluable disease per RECIST v1.1.
排除标准
- •Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may be eligible for the study, provided:
- •There is no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
- •Subjects who are receiving corticosteroids must be on a stable or decreasing dose for at least 4 weeks before first dose of study treatment.
- •Laboratory parameters outside the protocol-defined range.
- •Clinically significant abnormalities found on an ECG.
- •Clinically significant or uncontrolled cardiac disease.
- •Past history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
- •Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
- •Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or hormonal therapy).
- •Any previous use of Janus kinase (JAK) inhibitor, osimertinib, or other EGFR-directed therapy for T790M-mt NSCLC.
研究组 & 干预措施
Itacitinib + osimertinib
Experimental
干预措施: Itacitinib (Drug)
Itacitinib + osimertinib
Experimental
干预措施: Osimertinib (Drug)
结局指标
主要结局
Phase 1: Frequency, severity, and duration of adverse events (AEs)
时间窗: From screening through 30-35 days after end of treatment, approximately 2 years.
Phase 1: Number of subjects with dose-limiting toxicities (DLTs)
时间窗: Day 1 through Day 28
Phase 2: Objective response rate (ORR) based on RECIST v1.1
时间窗: Screening and 8-week intervals throughout the study, approximately 2 years.
ORR defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR).
次要结局
- Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination(Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.)
- Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC) of Itacitinib and osimertinib when administered in combination(Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.)
- Phase 2: Depth of response (DpR) based on RECIST v1.1(Screening and 8-week intervals throughout the study, approximately 2 years.)
- Phase 2: Progression-free survival (PFS)(Interval from the first day of study treatment until disease progression or death due to any cause, approximately 3 years.)
- Phase 2: Overall survival (OS)(Interval from the first day of study treatment until death due to any cause, approximately 3 years.)
- Phase 2: Frequency, severity, and duration of AEs(From screening through 30-35 days after end of treatment, approximately 2 years.)
研究者
研究点 (55)
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