JPRN-jRCT2031220600招募中2 期
Phase II study of Lorlatinib in LTK fusion-positive advanced non-small cell Lung cancer - 3L study
Yoh Kiyotaka0 个研究点目标入组 10 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Histologically or cytologically diagnosed as NSCLC.
- •2. Unresectable stage III without any indications for radical radiotherapy, stage IV or post-operative recurrence.
- •3. LTK fusion positivity was identified by analyzing tissue specimen using a measurement method validated in the LC-SCRUM-Asia.
- •4. Having at least 1 measurable lesion according to RECIST ver. 1.1.
- •5. Males and females aged 18 years or older at the time of informed consent for participation in the study.
- •6. Having ECOG PS of 0 to 2.
- •7. Having adequate organ function as defined in the laboratory criteria:
- •8. Patients who have been explained in writing about study-related information and signed the informed consent form before enrollment.
- •9. Patients who are able to visit the hospital on the scheduled dates and to actively cooperate and receive treatment, examinations and other procedures related to the study.
- •10. Patients who agree to effective contraception during the study period and for at least 97 days for men and 21 days for women of childbearing potential from the last dose of lorlatinib.
排除标准
- •1. Participating in another clinical trial and receiving treatment.
- •2. Being positive for ALK or ROS1 fusion genes
- •3. Receiving systemic chemotherapy or radiotherapy within 2 weeks prior to enrollment, or undergoing major surgery within 4 weeks before enrollment.
- •4. Patients with acute toxicities associated with prior treatment have not resolved to grade 1 or baseline levels.
- •5. Patients who have symptomatic brain metastases. Those who are asymptomatic, or who are receiving treatment and neurologically stable for at least 2 weeks, requiring no increase in corticosteroid dose, are eligible for enrollment.
- •6. Patients with spinal cord compression, carcinomatous meningitis, or leptomeningeal disease that do not have good pain control and have not maintained or restored neurologic function by treatment.
- •7. Patients with CT-confirmed or a history of pulmonary fibrosis or interstitial lung disease.
- •8. Patients with any of the history/comorbidities of cerebrovascular/cardiovascular diseases within 3 months before the start of the investigational drug administration;
- •9. Having active arrhythmia of >=Grade 2 according to CTCAE ver. 5.0, uncontrolled atrial fibrillation of any grade, and QTc > 470 msec, or congenital long QT syndrome.
- •10. Having an active and clinically significant bacterial, fungal, or viral infection, such as hepatitis B, hepatitis C and acquired immunodeficiency syndrome-related disease.
- •11. Patients who are pregnant or breastfeeding.
- •12. Use of any of the drugs or foods within 12 days before the initial administration of the investigational drug.
- •13. Affected by active malignancy in the past 3 years.
- •14. Patients with other serious acute or chronic medical conditions, psychiatric diseases, or laboratory abnormalities who are deemed by the principal investigator or sub-investigator to have a higher risk of progression by participating in the study or by receiving the investigational drug.
研究者
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