ACTRN12619000844145已完成1 期
A single arm multi-centre translational proof of concept study investigating the safety and efficacy of alternating lorlatinib with crizotinib in a pre-treated advanced ALK-rearranged non-small cell lung cancer population with disease progression on a 2nd generation ALK tyrosine kinase inhibitor
Royal North Shore Hospsital0 个研究点目标入组 15 人开始时间: 2019年6月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults aged >=18 years with pathologically confirmed stage IV ALK gene rearranged NSCLC (predominately adenocarcinoma phenotype) by IHC and or FISH, fresh or archival, not required to be reconfirmed centrally
- •Confirmed radiological disease progression on prior second generation ALKi as per RECIST Version 1.1
- •Any prior number of lines of systemic therapy, provided the most recent ALKi was a second generation agent
- •Extracranial RECIST measurable disease confirmed =28 days prior to start of study
- •Eastern Co-operative Oncology Group (ECOG) performance status =1
- •Patients with asymptomatic CNS disease including leptomeningeal disease are eligible
- •Patients with symptomatic CNS disease including leptomeningeal disease are eligible if treated with local therapy(ies) including surgery and or radiotherapy and stable clinically with stable steroid requirements for >=14 days
- •Patients with oligo-progression in the CNS are eligible, provided they meet criteria above Adequate bone marrow function (e.g. platelets > 100 x 109/L, ANC = 1.5 x 109/L, Hb =90)
- •Adequate liver function (e.g. ALT/AST < = 3 x ULN; if liver metastases <= 5 x ULN, bilirubin <= 2 x ULN)
- •Adequate renal function (e.g. creatinine clearance >= 50 ml/min, serum creatinine <= 1.5 x ULN)
- •Study treatment both planned and able to start within 14 days of registration
- •Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments (e.g. able to have IV contrast if this is required for tumour assessments)
- •Signed, written informed consent (for trial inclusion and tissue collection)
- •Prior screen failure patients are eligible for rescreening
排除标准
- •Most recent systemic treatment is crizotinib
- •Prior hypersensitivity to crizotinib
- •Primary resistance to first line ALKi therapy (first or second generation ALKi)
- •Prior lorlatinib therapy or other third generation ALKi therapy
- •Prior toxicity to crizotinib contraindicating further use
- •Previous ALKi therapy within 4 days, or chemotherapy or radiotherapy within 7 days
- •Specific comorbidities or conditions affecting compliance to clinical trial
- •Life expectancy of less than 3 months
- •Inability to tolerate or contraindication to MRI-B imaging
- •No measurable disease via RECIST criteria extra-cranially
- •Significant cardiac dysfunction
- •Untreated and or non-clinically stable symptomatic CNS including leptomeningeal disease
- •Past history of malignancy except the following whom are eligible: adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, or curatively treated cervical carcinoma in situ. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment, with the exception of men with prostate cancer, eligible if PSA and radiological control for at least 2 years
- •Significant uncontrolled infection, including chronic active hepatitis B, hepatitis C, or HIV.
- •Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •The requirement to continue one of the excluded concomitant medications (Section 8.6)
- •Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- •Comorbid malabsorption syndrome or other gastrointestinal (GI) illness or condition that could affect oral absorption of the study drug
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
- •Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
- •An inability to travel to the enrolled site to participate in the trial and all required visits
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