NCT06487078招募中不适用
LOREA : ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH NON INTERVENTIONAL STUDY
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 90
- 试验地点
- 32
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •Patients (male or female) 18 years of age or older at age inclusion
- •Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic (TNM 8th classification) ALK-positive NSCLC (IHC 3+/FISH positive/transcriptomic method)
- •Complete radiological evaluation has to be performed before the start of lorlatinib by contrast enhanced CT-scan of thorax and upper abdomen and brain MRI, as per routine care
- •Patients with ECOG performance status grade 0, 1, or 2
排除标准
- •Participants are excluded from the study if any of the following criteria Apply
- •Evidence of active malignancy within the last 2 years prior to inclusion (other than NSCLC, non-melanoma skin cancer, cervical in situ cancer, papillary thyroid cancer, lobular carcinoma in situ/ductal carcinoma in situ (LCIS/DCIS) of the breast, or localized prostate cancer).
- •Patients who have previously received adjuvant ALK TKI therapy (unless metastatic relapse occurs more than one year after completion of adjuvant therapy).
- •Patients who have previously received systemic NSCLC therapy in metastatic condition.
- •Patients using any of the following food or drugs within 12 days prior to the first dose of lorlatinib:
- •known strong CYP3A inhibitors
- •known strong CYP3A inducers
- •known P gp substrates with a narrow therapeutic index
- •Patients with any medical or psychiatric condition, or that may, in the investigator's judgment, increase the risk of study participation or make the participant inappropriate for the study.
- •Positive pregnancy test for females of childbearing potential.
- •Breastfeeding and childbearing potential female unwilling/unable to use a highly effective contraception method for the study duration and for at least 35 days after the last dose of lorlatinib
- •Fertile male patients unwilling/unable to use a highly effective method of contraception for the duration of the study and for at least 97 days after the last dose of lorlatinib.
- •Patients participating in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- •Patients deprived of their liberty, under protective custody or guardianship or unable to provide signed consent.
- •Patients not affiliated to the French social security system.
- •Patients opposed to the collection of their data.
- •Patients willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow-up.
- •Patients judged inapt to respond to the questions required for the study due to linguistical, psychological, social, or geographical reasons.
- •Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
研究组 & 干预措施
Lorlatinib
Experimental
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
干预措施: Lorlatinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From time of Study Start up to 25 months
Time from inclusion to date of disease progression or death of any cause whichever occurs first.
次要结局
- Overall Survival (OS)(From time of Study Start up to 25 months)
- Intracranial Duration of Response (IC-DR)(From time of Study Start up to 24 months)
- Adverse Event (AE) as graded by NCI CTCAE v5)(From time of Study Start up to 25 months)
- Proportion of patients experiencing grade III toxicities or progression and having an over- or under-exposure to lorlatinib.(At baseline, at start of Cycle1Day15 (each cycle is 28 days), Month 3, Month 9 and every 6 months through the end of treatment, at time of first grade III of hyperlipidaemia and CNS toxicity onset, and at progression - as long as 48 months)
- Proportion of patients experiencing each kind of identified lorlatinib resistance mechanisms(At baseline and at the date of first documented progression (as long as 48 months))
- Objective Response Rate (ORR)(From time of Study Start up to 24 months)
- Intracranial Time to Progression (IC-TTP)(From time of Study Start up to 24 months)
- Proportion of patients with extracranial progression and sites of progression(From time of Study Start up to 24 months)
- Number of Participants With Treatment-Emergent Adverse Events (AEs; Treatment-Related(From time of Study Start up to 25 months)
- Duration of Response (DR)(From time of Study Start up to 24 months)
- Duration of Treatment (DT)(From time of Study Start up to 25 months)
- Proportion of patients considered observant to treatment assessed by the compliance questionnaire.(At the start of cycle (each cyle is 28 days) Cycle2Day1, Cycle3Day1, Cycle4Day1 and then every 3 months - as long as 48 months)
- Proportion of patients experiencing a 10-points change from baseline in total score for the EORTC QLQ-C30(At inclusion, At the start of Cycle (each cycle is 28 days) Cycle2Day1, Cycle3Day1, Cycle4Day1 and every 3 months until the first year and then every 6 months - as long as 48 months)
- Proportion of patients experiencing a 10-points change from baseline in total score for the EORT QLQ-LC13.(At inclusion, At the start of Cycle (each cycle is 28 days) Cycle2Day1, Cycle3Day1, Cycle4Day1 and every 3 months until the first year and then every 6 months - as long as 48 months)
- Patient Reported Outcome-informed CNS symptomatic toxicity:(At inclusion, At the start of cycle (each cycle is 28 days) Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle4Day1 and every 3 months until the first year and then every 6 months - as long as 48 months)
- Intracranial Objective Response Rate (IC-ORR)(From time of Study Start up to 24 months)
- Time to Treatment Failure (TTF)(From time of Study Start up to 24 months)
研究者
研究点 (32)
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