NL-OMON55136招募中2 期
Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor - EORTC 1825-LCG/ALKALINE
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
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 64（—）
入选标准
- •Age >=18 years old
- •Histologically or cytologically confirmed diagnosis of NSCLC with ALK
- •rearrangement, assessed by FISH assay (Abbott Molecular Inc) or by
- •Immunohistochemistry (IHC) (Ventana Inc) approved by FDA. Liquid biopsy is an
- •acceptable method for the diagnosis of ALK rearrangement in case there is no
- •leftover biopsy/cytological specimen.
- •Stage III (not eligible for local therapy) or stage IV (according to UICC TNM
- •staging v8.0)
- •WHO performance status (WHO PS) of 0-2
- •Previous treatment with at least one 2nd-generation ALK inhibitor. The
- •2nd-generation ALK TKI (including but not limited ceritinib, alectinib,
- •brigatinib) should be the latest therapy.
- •Progressive disease during treatment with 2nd-generation ALK inhibitor prior
- •to the administration of lorlatinib
- •Measurable disease according to RECIST version 1.1 by computed tomography
- •(CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI
- •performed within 28 days prior to study enrolment
- •Collection of blood sample for cohort allocation.
- •Note: if blood sample cannot be collected (patient's refusal or any other
- •reason), patient will not be eligible for this study
- •Treated and/or untreated brain or leptomeningeal metastases will be allowed
- •if asymptomatic and/or controlled (stable dose of steroids 7 days before the
- •beginning of lorlatinib treatment)
- •Adequate bone marrow and organ function
- •Women of child bearing potential (WOCBP) must have a negative serum pregnancy
- •test within 3 days prior to the first dose of lorlatinib
- •Women of childbearing potential must use a highly effective non-hormonal
- •method of contraception during the study treatment period and for at least 35
- •days after the last dose of lorlatinib. If a hormonal method of contraception
- •is unavoidable, then a condom must be used in combination with the hormonal
- •Male patients with female partners of childbearing potential must use
- •effective contraception, including a condom, and male patients with pregnant
- •partners must use condoms, during the study treatment period and for at least
- •14 weeks after the last dose of lorlatinib.
- •Female subjects who are breast feeding should discontinue nursing prior to
- •the first dose of study treatment and until 7 days after the last dose of
- •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
- •Before patient registration, written informed consent must be given according
- •to ICH/GCP, and national/local regulations
- •Enrolment in optional prospective sub-study:
- •The patient has received at least 6 months of second generation ALK-TKI
- •therapy (if crizotinib-pretreated)
- •The patient has received at least 12 months of second generation ALK-TKI
- •therapy (if crizotinib-naïve)
- •Patient is willing and able to comply with the sub-study requirements
- •including scheduled visits and examinations including follow up
- •Before patient registration, written informed consent must be given according
- •to ICH/GCP, and national/local regulations
排除标准
- •Spinal cord compression. Patients who received adequate treatment (surgery or
- •radiotherapy) and has adequate control of the pain and stabilization and/or
- •recovery of neurological symptoms/function for the 3 weeks prior to study entry
- •are allowed
- •Major surgery within 4 weeks prior to study enrolment. Complete wound healing
- •from major surgery must have occurred 3 weeks before the first dose of study
- •Minor surgical procedures (including port insertion, uncomplicated tooth
- •extractions) without complete wound healing at the latest 1 week before the
- •first dose of study treatment.
- •Radiation therapy within 2 weeks of study entry
- •Any systemic anti-cancer therapy or an investigational drug treatment
- •completed within 7 days prior to start lorlatinib (in case of clinically
- •meaningful risk of tumour flare according to investigator's assessment,
- •discussion with EORTC is required before enrolment)
- •Any unresolved toxicities from prior systemic therapy
- •Active infection requiring therapy
- •Known active hepatitis B (HBV) or hepatitis C (HCV).
- •Known human immunodeficiency virus (HIV), or acquired immunodeficiency
- •syndrome (AIDS)-related illness
- •Any of the following cardiac criteria:
- •Clinically significant cardiovascular disease (that is active or occurred <3
- •months prior to enrolment): cerebral vascular accident/stroke, myocardial
- •infarction, unstable angina, congestive heart failure (New York Heart
- •Association Classification Class >= II), second-degree or third-degree AV block
- •(unless paced) or any AV block with PR >220 msec
- •Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial
- •fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is
- •otherwise healthy such as long-distance runners, etc.)
- •Abnormal Left Ventricular Ejection Fraction (LVEF): LVEF <50% (assessed by
- •MUGA or ECHO)
- •History of interstitial lung disease (ILD) or history of (non-infectious)
- •pneumonitis that required oral or IV steroids (other than COPD exacerbation) or
- •current pneumonitis or current evidence of interstitial lung disease. Patients
- •with history of prior radiation pneumonitis are not excluded
- •Any serious or uncontrolled acute or chronic medical or psychiatric
- •condition, including recent (within the past year) or active suicidal ideation
- •or behaviour, chronic alcoholism, drug addiction, or laboratory abnormality
- •that may increase the risk associated with study participation or
- •investigational product administration or may interfere with the interpretation
- •of study results and, in the judgment of the investigator, would make the
- •patient not eligible for this study
- •Hereditary problems of galactose intolerance, total lactase deficiency, or
- •glucose-galactose malabsorption
- •Inability to swallow and/or retain oral tablets or impaired gastrointestinal
- •function or disease that may significantly alter the absorption of lorlatinib
- •(e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome,
- •small bowel resection with decreased intestinal absorption)
- •Evidence of active hematologic or primary solid tumour malignancy (other than
- •completely resected non-melanoma skin cancer, successfully treated in situ
- •carcinoma for example in situ cervical cancer, completely resected and
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研究者
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