CTIS2023-506714-43-00招募中1 期
A multicenter single-arm phase II interventional study to evaluate the activity and safety of the combination of Platinum-Pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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 65+（—）
- 性别
- All
入选标准
- •Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained, and documented according to the local regulatory requirements, Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC, For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 14 weeks after the last dose of study drugs, Age at the time of signing the informed consent at least 18 years, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC. ALK positivity can be determined by fluorescence in situ hybridization assay (FISH), immunohistochemistry (IHC) or DNA-based next-generation sequencing (NGS), Patients must have measurable disease according to RECIST 1.1 by computed tomography (CT) and magnetic resonance imaging (MRI), patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in first- or further-line, without limitations regarding previously received therapies. If a patient has already received platinum (e.g. in adjuvant setting), the eligibility for PT-pem chemotherapy treatment is at the Investigator discretion, Radiologically confirmed multiple extracranial progression on Lorlatinib without progression in the central nervous system (CNS) defined as: •Absence of CNS metastasis •CNS metastasis stable on Lorlatinib and/or stereotactic brain irradiation (SBRT) •Prior radiotherapy must have been completed within 4 weeks of study entry; SBRT must have been completed at least 4 weeks before study entry; and whole-brain radiotherapy at least 4 weeks before study entry. •Patients with previously treated brain metastases are eligible provided they have been clinically stable for at least 4 weeks with no evidence of new or expanding brain metastases, Adequate organ function (kidney, bone marrow and liver): - Hematology •Absolute Neutrophil Count (ANC) =1.5 x 109 / L •Platelets =100 x 109 / L •Hemoglobin =10 g/dL (=6.2 mmol/L) - Hepatic function •Total bilirubin <1.25x UNL. In presence of a documented history of Gilbert syndrome the total bilirubin level must be <3.0x UNL •AST and ALT =1.5x UNL. If the liver has tumor involvement AST and ALT must be =5x UNL •Alkaline phosphatase =2.5x UNL - Renal Function •<1.25x ULN creatinine •Creatinine clearance =45 ml/min (according to Cockroft-Gault, if creatinine is above UNL), If feasible, fresh tissue biopsy demonstrating ALK translocation still present (obtained = 3 months before study enrolment), assessed by local laboratory
排除标准
- •Known hypersensitivity reaction to one of the compounds or substances used in this protocol, Diagnosis of any secondary malignancy within the last 3 years, except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy, Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination, Presence of toxicities contraindicating the continuation of therapy with Lorlatinib, Concomitant use of potent CYP3A4/5 inducers
研究者
相似试验
进行中（未招募）
1 期
DALY II USA/MB-CART2019.1 for DLBCCTIS2023-508508-39-01Miltenyi Biomedicine GmbH110
进行中（未招募）
1 期
Safety evaluation of neoadjuvant Myocet® plus paclitaxel, trastuzumab, and pertuzumab in patients with operable HER2-positive breast cancerHER2-positive breast cancerMedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 100000004864EUCTR2012-001201-24-ESSOLTI83
招募中
1 期
A multicentre, Phase II, single-arm, interventional study of neoadjuvant durvalumab and platinum-based chemotherapy (CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with resectable or borderline resectable stage IIB-IIIB Nonsmall Cell Lung Cancer (NSCLC)on-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-503357-35-00AstraZeneca AB140
进行中（未招募）
1 期
Research study to determine whether a drug called obinutuzumab given to persons with relapsed and refractory Waldenström Macroglobulinemia in induction therapy followed by two years of maintenance is safe and efficacious.EUCTR2016-005053-20-PLPolish Myeloma Consortium30
进行中（未招募）
1 期
Clinical study aimed to assess in patients with triple-negative operable breast cancer the activity of the drug zoledronate administered before surgery, according to the the tumor aggressiveness (determined by the level of expression of the p53 protein)ewly diagnosed, untreated, operable triple negative breast cancerMedDRA version: 18.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-004194-16-ITIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI21