NL-OMON55798招募中2 期
Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial. - The position-20 trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Patients must be >= 18 years of age.
- •3. Locally advanced or metastatic non-small cell lung cancer, not amenable to
- •curative surgery or radiotherapy
- •4. Presence of an EGFR exon 20, non-T790M, mutation, deletions and/or insertion
- •5. ECOG performance score of 0-2
- •6. Patients must have a life expectancy >= 12 weeks.
- •7. 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 two weeks before
- •screening. Male patients should be willing to use barrier contraception.
- •8. 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.
- •9. At least one lesion, not previously irradiated, that can be accurately
- •measured at baseline as >= 10 mm in the longest diameter (except lymph nodes
- •which must have short axis >= 15 mm) with computed tomography (CT) or magnetic
- •resonance imaging (MRI) and which is suitable for accurate repeated
- •measurements.
- •10. Brain metastasis, if asymptomatic, are allowed. In case of symptomatic
- •brain metastasis, patient must have had radiotherapy and stable for at least 2
排除标准
- •1. Presence of a T790M mutation or other tumour driven mutations,
- •translocations or amplifications (e.g. common EGFR mutations, KRAS, BRAF V600E,
- •ALK, ROS1)
- •2. Patient is unwilling and unable to comply with the protocol for the duration
- •of the study including undergoing treatment and scheduled visits and
- •examinations including follow up
- •3. Previous treatment with EGFR-TKI
- •4. 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 inducers of CYP3A4 (at least 3 weeks prior).
- •5. 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 or immune mediated pneumonitis or hepatitis
- •previously treated with IO therapy.
- •6. Any evidence of severe or uncontrolled systemic diseases, including
- •uncontrolled hypertension and active bleeding diatheses.
- •7. Patients with symptomatic central nervous system (CNS) metastases who are
- •neurologically unstable
- •8. Past medical history of interstitial lung disease (ILD), drug-induced ILD,
- •radiation pneumonitis requiring steroid treatment, or any evidence of
- •clinically active ILD
- •9. Inadequate bone marrow reserve or organ function.
- •10. Any of the following cardiac criteria:
- •- Mean resting corrected QT interval (QTc) > 470 msec obtained from 1
- •electrocardiograms, using the screening clinic ECG machine derived QTc value
- •- Any clinically important abnormalities in rhythm, conduction or morphology of
- •resting ECG (e.g., complete left bundle branch block, third degree heart block,
- •second degree heart block)
- •- Any factors that increase the risk of QTc prolongation or risk of arrhythmic
- •events such as heart failure, hypokalemia, congenital long QT syndrome, family
- •history of long QT syndrome or unexplained sudden death under 40 years of age
- •in first degree relatives or any concomitant medication known to prolong the QT
- •11. 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
- •12. 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
- •13. 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
- •14. History of hypersensitivity active or inactive excipients of osimertinib or
- •drugs with a similar chemical structure or class to osimertinib
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