NCT03414814已完成2 期
Phase II Study of Osimertinib in NSCLC Patients With EGFR Exon 20 Insertion Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.
详细描述
EGFR exon 20 insertion-mutant NSCLCs are generally resistant to 1st-generation EGFR tyrosine kinase inhibitors (TKIs) as well as 2nd-generation EGFR TKIs (overall response rates of 0-8.7%). Osimertinib is an oral, potent, irreversible EGFR-TKI selective for sensitizing EGFR and EGFR T790M resistance mutations with a significant selectivity margin against wild-type EGFR. Osimertinib is potent with a wide therapeutic window in Ba/F3 cells with EGFR exon 20 insertion mutations. Therefore, this study will be performed to investigate the efficacy of osimertinib in NSCLC patients with EGFR exon 20 insertion mutation
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Male or female must be > 19 years of age.
- •Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy with local confirmation of the presence of the EGFR exon 20 insertion mutation
- •Disease progression while on standard chemotherapy (platinum doublet chemotherapy or single-agent chemotherapy in selected patients)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have a life expectancy ≥ 12 weeks
- •Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- •Male patients should be willing to use barrier contraception
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •At least one measurable lesion
- •Provision of archival FFPE tissue
- •Provision of informed consent for translational genetic research
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)
- •Previous treatment with osimertinib (3rd generation EGFR TKIs such as olumtinib, EGF816 etc)
- •Treatment with an investigational drug within five half-lives of the compound
- •Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix A). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A
- •Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
- •Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- •Patients with symptomatic CNS metastases who are neurologically unstable; however, those with asymptomatic CNS metastases who do not require steroids for at least 4 weeks prior to start of osimertinib are eligible.
- •Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- •Inadequate bone marrow reserve or organ function
- •QTc prolongation (mean resting corrected QTc > 470 msec)
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
- •History of hypersensitivity to osimertinib (or drugs with a similar chemical structure or class to osimertinib) or any excipients of these agents
- •Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry
- •Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- •Previous allogeneic bone marrow transplant.
- •Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
研究组 & 干预措施
Osimertinib
Experimental
Osimertinib at 80mg dose will be administered orally once daily.
干预措施: Osimertinib 80 MG [Tagrisso] (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)
Investigator-assessed, confirmed objective response by RECIST version 1.1
次要结局
- Serious Adverse Events(From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawal, whichever came first. Until study completion. (upto about 29months))
- Progression-free Survival(From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months))
- Overall Survival(From the first date of IP administration to the date of death. (upto about 29months))
研究者
Tae Min Kim
Associate Professor
Seoul National University Hospital
研究点 (1)
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