[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-gene-rearrangement-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-gene-rearrangement-positive":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100448695","analysis-of-biological-characteristics-of-advanced-alk-rearranged-nsclc-100448695",false,"NCT05122806","Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC","Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study","BIOEXALK","Inclusion Criteria:\n\n* Stage IIIB\u002FIV NSCLC non eligible to locoregional treatment with curative intent\n* ALK rearrangement confirmed by IHC and\u002For FISH or NGS according to local methods\n* Patient included in the EXPLORE ALK study\n* Age \\> or = 18 years\n* Patient treated with first-line new generation ALKi\n* Patient agrees to sign an informed consent form and to collect blood samples at inclusion, first tumor evaluation and progression and for whom tumor biopsy at diagnosis is available\n* Patient enrolled in the french National Health Insurance program or with a third- party payer\n\nExclusion Criteria:\n\n* Patients who do not wish to participate in Bioexalk\n* Patients under guardianship","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients.\n\nBioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study.\n\nBiological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA).\n\nFor plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon).\n\nBiological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.",[27,28],"Non-small Cell Lung Cancer","ALK Gene Rearrangement Positive","RECRUITING","2026-04-24",{"date":32,"type":33},"2026-04-29","ACTUAL",{"date":35,"type":33},"2021-09-22",{"date":37,"type":21},"2027-06-30",{"name":39,"class":40},"Groupe Francais De Pneumo-Cancerologie","OTHER",46,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":67,"locationsCount":70},"100373755","expanded-access-to-ensartinib-for-participants-with-alk-nsclc-100373755","NCT04146571","Expanded Access to Ensartinib for Participants With ALK+ NSCLC","Expanded Access Intermediate-Size Patient Population Protocol","Inclusion Criteria:\n\n1. Adult patients (\\>18 years-of-age) with advanced ALK-positive NSCLC as determined by an FDA approved test.\n2. Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.\n3. Informed consent must be provided by each patient.\n4. Patient is not eligible or does not have access for participation in any of the other ongoing clinical trials for ensartinib.\n5. Ability to swallow and retain oral medication.\n6. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.\n7. Adequate organ system function.\n8. Patients with treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids. ALK-positive patients with untreated CNS lesions may be allowed to enroll as long as the patients are asymptomatic with respect to the CNS metastases and do not require systemic corticosteroids or anticonvulsants.\n\nExclusion Criteria:\n\n1. Patients currently receiving cancer therapy.\n2. Use of an investigational or targeted drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib. A minimum of 10 days between termination of the treatment and administration of ensartinib is required. However, in the case of ALK TKIs, a 2-day window between termination of the TKI and the start of ensartinib is allowed. In addition, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia.\n3. Any major surgery or immunotherapy within the last 21 days (focal radiation does not require a washout period; ≥4 weeks for whole brain radiotherapy). Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.\n4. Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib (e.g., crizotinib) or to the active ingredient of ensartinib or to tartrazine, a dye used in the ensartinib 100 mg capsules.\n5. Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.\n6. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib.\n7. Clinically significant cardiovascular disease.\n8. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.\n9. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n10. Have a history or the presence at baseline of pulmonary interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis.\n11. Females who are pregnant or breastfeeding.\n12. Patient with any concurrent condition or receiving any concurrent medication that, in the investigator's opinion, would impart excessive risk associated with study participation or otherwise make it inappropriate for the patient to participate.","EXPANDED_ACCESS","This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).",[52,28],"Non-Small Cell Lung Cancer",[54,55,56,57,58,59,60,52,61,62],"ensartinib","X-396","X396","anaplastic lymphoma kinase","ALK+","ALK positive","NSCLC","ALK inhibitor","carcinoma","AVAILABLE","2022-10-18",{"date":66,"type":33},"2022-10-20",{"name":68,"class":69},"Xcovery Holdings, Inc.","INDUSTRY",4]