JPRN-jRCTs071180007已完成2 期
A phase II trial of osimertinib as first-line treatment for elderly epidermal growth factor receptor mutation-positive advanced or postoperative recurrent non-small-cell lung cancer patients - SPIRAL-0 Study
Takayama Koichi0 个研究点目标入组 41 人开始时间: 2018年11月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
We investigate the efficacy and safety of osimertinib as a first-line treatment for elderly Japanese patients with EGFR mutation-positive advanced NSCLC. The 1-year PFS rate, the study's primary endpoint, was 59.4%, which did not meet the primary endpoint. Although the development of pneumonitis needs to be considered, osimertinib is tolerable and has potential as a 1st-line treatment option for elderly patients with EGFR mutation-positive advanced NSCLC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients >= 75 years old (at the time of providing informed consent)
- •2.Patients with histologically or cytologically confirmed non-small cell lung cancer
- •3.Patients at a stage of IIIB/IIIC or IV who are inoperable or who experienced postoperative recurrence
- •4.Patients with EGFR mutation (exon 19 deletion,L858R), which is known to be associated with EGFR-TKI sensitivity
- •5.Treatment naive(including EGFR-TKI, immune checkpoint inhibitor).Preoperative and/or postoperative treatment is permitted (including chemotherapy,radiation therapy,investigational new drug. However,immune checkpoint inhibitor is excluded including investigational new drug)
- •6.Patients able to have oral drugs
- •7.Patients with at least 1 measurable lesion according to RECIST v1.1 criteria
- •8.Patients with performance status (ECOG) of 0-2
- •9.Patients with normal major organ functions (bone marrow, liver, kidney, etc.) and who satisfy the following criteria in a test within 2 weeks prior to registration (the test on the same day of the week as the day 2 weeks before the registration is permitted.)
- •White blood cell count>= 3.0x10^3/uL -12.0x10^3/uL
- •Neutrophil count >= 1.5x10^3/uL
- •Platelet count >= 100x^10^3/uL
- •Hemoglobin >= 9.0 g/dl
- •AST <= 2.5xULN
- •ALT<= 2.5xULN
- •Serum bilirubin <= 1.5xULN
- •Serum creatinine <= 1.5xULN
- •SpO2 (Room air)>=90%
- •10.Patient expected to survive at least for 3 months.
- •11.Patients who have wash out of at least the following period from the prior treatment as of the treatment initiation date (registration is allowed on and after the same day of the week as the day after the following period).
- •Chemotherapy (preoperative/postoperative adjuvant chemotherapy): Longer than 4 weeks after the last administration date Radiotherapy:definitive thoracic radiotherapy:Longer than 12 weeks after the last radiation date
- •Other radiation therapy:Longer than 2 weeks after the last radiation date
- •Surgery/intervention (inclusive of thoracic drainage):Longer than 4 weeks after the last surgery/intervention date
- •12.Patients who provided written informed consent by themselves
排除标准
- •1.Patients with complications of pulmonary disorders such as interstitial lung disease (ILD), drug-induced ILD,radiation pneumonitis has been needed for steroid treatment,etc.
- •2.Patients with complications of infectious diseases requiring intravenous administration of antibacterial or antifungal agents
- •3.Patients who has any of the following QTc-prolongation risks:
- •1)The mean corrected QT interval at rest of >470 msec (Fridericia correction:QTc)
- •2)Clinically important abnormalities (for example, complete left bundle branch block, third-degree heart block, second-degree heart block) in the rhythm, conduction or waveform of electrocardiogram at rest.
- •3) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- •Electrolyte imbalance (serum/plasma potassium level <3.6mmol/L,serum/plasma magnesium level <1.8 mg/dL,serum/plasma calcium level <8.8mg/dL)
- •Heart failure, 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 interval.
- •4.Male patients without intention preventing contraception (Male patients should use condom during treatment period and 4 months after the final study drug administration. Male patients should refrain from providing a sperm during treatment period and 4 months after the final study drug administration).
- •5.Patients with active multiple primary cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer-free period of not more than 5 years; however, lesions such as carcinoma in situ and intramucosal carcinoma deemed to be cured by local treatment is not included as an active multiple cancer).
- •6.Patients with spinal cord compression or unstable symptomatic brain metastasis (however, it is eligible if neurological function of patient becomes clinically stable by radical treatment and it passed more than 14 days after steroid withdrawal)
- •7.patients who received treatment of other investigational new drugs at 5 times of elimination half-time of its compound or at 3 months (either short one) if patients have treatment history of investigational new drugs.
- •8.Patients with uncontrolled diabetes
- •9.Patients with anamneses such as refractory nausea and vomiting, chronic digestive organ disease or pharmaceutical preparation aphagia, or gastroeneterectomy that may remarkably influence osimertinib absorption.
- •10.Patients with sustained more than grade 2 toxicity (CTCAE) caused by pre-treatment (excluding alopecia and grade 2 neurotoxicity by pre-treatment of platinum preparation)
- •11.Patients with anamnesis of hypersensitivity to osimertinib (or similar chemical structure with osimertinib or same class drugs) or its vehicle.
- •12.Patients with clinically important complications
- •(such as uncontrollable hypertension, cardiac disease, severe cardiac arrhythmia to need medical treatment, sustained watery diarrhoea or hepatitis B, hepatitis C and active infections including human immunodeficiency virus (HIV) infection, and so on)
- •13.Patients judged as ineligible to participate in this study by the investigator.
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