EUCTR2019-002805-23-FR进行中（未招募）1 期
A Phase II, multi-centre study, to evaluate the efficacy and safety of osimertinib treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC) with Brain or Leptomeningeal metastases
IFCT0 个研究点目标入组 112 人开始时间: 2019年10月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Patient with NSCLC (histological or cytological diagnosis) stage IV (8th UICC TNM edition, 2017).
- •2.Patients with brain and/or leptomeningeal metastases.
- •For cohort 1, the diagnosis of leptomeningeal metastasis requires either ? detection of cancer cell or EGFR mutation in the CSF, or ? presence of both clinical and neuro-imaging findings typical of LM, according to EANO-ESMO criteria.
- •3.Presence of an activating EGFR mutation. The following mutations are considered to be activating: L858R, exon 19 deletions, exon 19 insertions, L861Q, G719X. The inclusion of patients with other mutations should be discussed on a case-by-case basis with IFCT.
- •The presence of co-mutations on an oncogenic driver should be discussed with the IFCT before inclusion of the patient.
- •4.Testing for T790M mutation in circulating tumour DNA or tumour tissue sample at progression on the last treatment received before inclusion.
- •5.Maximum lines of anti-cancer treatment received before inclusion:
- •oFor Cohort 1, patients could have been previously treated with maximum 3 lines of anti-cancer treatment.
- •oFor cohort 2, patients could have been previously treated with maximum 1 line of anti-cancer treatment.
- •oFor cohorts 3 and 4, patients could have been previously treated with maximum 2 lines of anti-cancer treatment. The line just before enrolment must be an EGFR TKI.
- •In case of previous chemotherapy, a wash-out period of 28 days will be applied. If there was any prior therapy with an investigational agent, a washout period of five half-lives of the compound or 3 months, whichever is greater, is needed.
- •6.Patient having recovered from all grade = 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where =2 is allowed).
- •7.For cohorts 3 and 4, documented tumour progression after previous therapy according to RECIST 1.1 :
- •- Cohort 3: patients must have progressive brain metastases but no extra-CNS progression.
- •- Cohort 4: patients must have progressive brain metastases and extra-CNS progression.
- •8.Presence of at least one evaluable lesion not previously irradiated according to RECIST 1.1. For cohort 2, 3 and 4, presence of one CNS evaluable lesion not previously irradiated according to RECIST 1.1.
- •9.Age of at least 18 years old.
- •10.Performance status (PS) 0 to 2 (ECOG) except for patients with leptomeningeal carcinomatosis (cohort 1) a PS 3 is authorised.
- •11.Patient with a life expectancy of = 6 weeks for cohort 1 and = 12 weeks for cohort 2, 3 and 4.
- •12.Haematological function:
- •- Absolute number of neutrophils = 1.5 x 109/L;
- •- Platelets = 100 x 109/L;
- •- Haemoglobin = 9 g/dL (transfusions to maintain or exceed this value are accepted).
- •13.Hepatic function:
- •- Total bilirubin = 1.5 x UNL (Upper Normal Limit) or = 3 x UNL in case of documented Gilbert’s syndrome or liver metastases;
- •- AST / ALT < 2.5 x UNL if no liver metastases or < 5 x UNL in case of liver metastases.
- •14.Renal function: Creatinine =1.5 x UNL. If creatinine > 1.5 x UNL, Creatinine clearance
排除标准
- •1.Small cell lung cancer histology (SCLC) or tumours with mixt histology including a SCLC component.
- •2.Previous treatment with osimertinib or another 3rd generation EGFR inhibitor.
- •3.Previous treatment with any EGFR TKI (cohort 2 only)
- •4.Brain progression requiring whole brain radiation without delay.
- •5.Local treatments (neurosurgical or stereotactic treatment) for brain metastases performed less than 2 weeks prior to enrolment.
- •6.Local brain treatment scheduled during study treatment.
- •7.Patient who received radiotherapy including the lung fields = 4 weeks before enrolment or patient who has not recovered from radiotherapy-induced toxicities. For all other body sites (including radiotherapy on thoracic vertebrae and ribs), radiotherapy = 2 weeks before enrolment or who have not recovered from radiotherapy-induced toxicities. Palliative radiotherapy for bone lesions = 2 weeks before enrolment is authorised.
- •8.Any of the following cardiac criteria:
- •-Mean resting corrected QT interval (QTc) > 470 msec using the screening clinic ECG machine derived QTc value
- •-Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block and second degree heart block).
- •-Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/plasma potassium < LLN; Serum/plasma magnesium < LLN; Serum/plasma calcium < LLN), 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 and cause Torsades de Pointes.
- •9.Active malignant disease other than NSCLC.
- •10.Previous or active cancer within the previous 3 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
- •11.Others on-going anti-cancer treatment (including hormone therapy).
- •12.Major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic) during the 4 weeks before enrolment or patient who has not recovered from the side effects of such as procedure.
- •13.Current severe infectious disease or fever > 38.5°C or evidence of any other pathology, degradation of organic or neurological functions, result of the physical examination or laboratory tests leading to suspect disease or a condition contra-indicating the use of the study treatment, which can impair the patient’s compliance to the protocol conditions or expose to any possible risk of complications related to treatment.
- •14.Clinically significant heart disease (e.g. active): stroke or myocardial infarction in the 6 months prior to inclusion, unstable angina, congestive heart failure grade > II according to New York Heart Association (NYHA) parameters, or cardiac arrhythmia requiring specific treatment during the study which could interfere with study compliance or which is not controlled by a treatment.
- •15.Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to partic
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