[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe Francais De Pneumo-Cancerologie\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,67],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100563797","phase-2-trial-for-local-ablative-treatment-lat-optimization-in-patients-with-advanced-non-small-cells-lung-cancer-nsclc-presenting-an-anaplastic-lymphoma-kinase-alk-rearrangement-treated-by-brigatinib-100563797",false,"NCT06620835","Trial for Local Ablative Treatment (LAT) Optimization in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) Presenting an Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib","Optimization of Treatment With Brigatinib in Patients With Advanced NSCLC Harboring an ALK Rearrangement by LAT at the Time of Best Response: A Multicenter Open Phase Two Trial (OPTALK)","OPTALK","Inclusion Criteria:\n\n* Age 18 years or older at diagnosis.\n* Stage 3 non eligible for chemoradiotherapy or stage 4 NSCLC, histologically or cytologically confirmed NSCLC.\n* Tyrosine Kinase Inhibitor (TKI) treatment naïve.\n* ALK rearrangements identified by a validated technique (either Immunohistochimy (IHC), fluorescence in situ hybridization (FISH) or Ribonucleic Acid (RNA)seq, in tissue or liquid biopsy)\n* Stable disease or response after initiation brigatinib treatment (at least 3 to 9 months) according to RECIST 1.1\n* At least one site of residual site for LAT (ie. participant should not have a complete response)\n* Oligometastatic disease (five metastatic lesions or less and a maximum of two lesions per organ) de novo or induced\n* Eligible for local ablative treatment possible (either alone or combined): surgery, minimally invasive form of surgical radiosurgery (Stereotactic Radio Surgery (SRS)) (18 to 20 Gy in single fraction) or radiotherapy (SBRT) (27 to 54 Gy in 3 fractions or 45 to 50 Gy in 5 fractions), radiofrequency or cryotherapy (=thermoablation)\n* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.\n* Life expectancy above 12 weeks as assessed by treating investigator.\n* Brain metastases at inclusion are allowed if asymptomatic\n* No history of other malignant tumor during the previous 5 years, except for adequately treated carcinomas (in situ cervical carcinoma, basal cell carcinoma, squamous cell skin carcinoma) and low-grade localized prostate cancer (Gleason \\<6).\n* Adequate organ function, as demonstrated by laboratory results prior to the first administration of study treatment: normal hepatic function (bilirubin ≤1.5 x upper limit of normal (ULN), alanine aminotransferase (ALA T) and aspartate aminotransferase (ASAT) ≤2.5 x ULN or ≤5 x ULN in case of liver metastases), renal function (calculated creatinine clearance (CrCl, using local formula) above 45 ml\u002Fmn), normal hematological function (absolute neutrophil count\n\n  ≥1.5 x 109\u002FL and\u002For platelets ≥100 x 109\u002FL, hemoglobin ≥8 g\u002FdL), normal coagulation function (International Normalized Ratio (INR) or prothrombin time ≤1.5 x ULN and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 x ULN unless the patient is receiving anticoagulant therapy)\n* For patients of childbearing potential: Women of childbearing potential should use effective non-hormonal contraception during treatment with brigatinib and for at least 4 months following the final dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose of brigatinib.\n* Signed informed consent to participate in the study\n* Affiliation with or benefit from French social security\n\nExclusion Criteria:\n\n* NSCLC without known ALK rearrangements\n* Neuroendocrine tumor (even in case of mixed tumors).\n* Uncontrolled and untreated superior cava syndrome.\n* Unstable symptomatic brain metastases despite corticosteroid\n* Leptomeningeal, pericardial, pleural and mesenteric lesions, lymphangitic spread (any tumoral lesions not amenable to definitive local therapy). Peri tumoral lymphangitic spread around a tumor, but limited to a lobe, may be treated by surgery).\n* Serious concurrent conditions during the previous 6 months (severe or unstable angina pectoris, coronary or peripheral artery bypass graft of \\<6 months, class 3 or 4 congestive heart failure, ischemic stroke, grade ≥2 peripheral neuropathy, psychiatric or neurological disorders that may interfere with the patient's understanding of the study or with his\u002Fher informed consent.\n* Severe or non-controlled systemic diseases deemed incompatible with the protocol.\n* Severe infections within 4 weeks prior to inclusion, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Psychological, family, social, or geographical factors that may interfere with the monitoring of the patient as defined by the protocol.\n* Any protected person (legal person protected by legal protection \\[guardianship, tutorship\\], person deprived of liberty, pregnant woman, breastfeeding woman, and minor).\n* Patients who participated in other concomitant studies unless observational and received study therapy or used an investigational device within 4 weeks prior to start of study treatment\n* Known allergies or adverse reactions to the study drugs\n* Lung function not compatible with surgery or radiation","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered when the brigatinib works best in participants presenting an advanced non-small cells lung cancer with an ALK gene anomaly (this anomaly produces a defective protein that is responsible for the multiplication of cancer cells).\n\nThis clinical trial is expected to involve 45 participants in several sites in France.\n\nAdvanced non-small cell lung cancer (NSCLC) participants with ALK rearrangements treated with brigatinib in first line of non-curable setting will be screened.\n\nIf the disease assessment done between 3 to 9 months after initiation of brigatinib shows:\n\n* a tumor response or stabilization (according to RECIST 1.1)\n* a disease which meets the definition of an oligometastatic disease (five metastatic lesions or less and a maximum of two lesions per organ)\n* all tumor targets are accessible to a local ablative therapy (confirmed by an expert panel of clinicians before inclusion): surgery, stereotactic radiosurgery (SRS). For liver, adrenal, or other metastases, percutaneous thermal ablation will be accepted.\n\nParticipants will be asked to visit the clinic:\n\n* for eligibility criteria assessment prior to LAT\n* for LAT\n* every 8 weeks for checkups and tests the first year after LAT\n* and then every 12 weeks, for a maximum period of 3 years.\n\nEligible patients will benefit from local ablative therapy with continuation of brigatinib.",[27],"NSCLC",[27,29,30,31],"Lung cancer","ALK rearrangement","gene mutation","RECRUITING","2026-04-24",{"date":35,"type":36},"2026-04-29","ACTUAL",{"date":38,"type":36},"2025-06-19",{"date":40,"type":21},"2030-10-01",{"name":42,"class":43},"Groupe Francais De Pneumo-Cancerologie","OTHER",27,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100535130","mechanisms-of-resistance-to-amivantamab-in-patients-with-nsclc-with-egfr-exon-20-insertion-100535130","NCT06247826","Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion","RESAMEX","Inclusion Criteria:\n\n* All patients with advanced NSCLC with EGFR ins20 receiving amivantamab as monotherapy in France under ATU or EAP;\n* Age ≥ 18 years;\n* Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectable and not suitable for definitive radiotherapy) with EGFR ins20;\n* Patients included will be required to sign an informed consent form to collect blood samples (liquid biopsy) and tissue biopsy when available at progression on amivantamab;\n* Confirmed progression on amivantamab according to RECIST 1.1;\n* Patient enrolled in the french National Health Insurance program or with a third- party payer.\n\nExclusion Criteria:\n\n* Patients receiving amivantamab in combination with another therapy;\n* Patients who do not consent to liquid biopsy at progression.",{"count":53,"type":21},30,[55],"NA","The goal of this prospective, interventional study is to evaluate the mechanisms of acquired resistance to amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20. The main question it aims to answer is:\n\nWhat are the mechanisms of acquired resistance to amivantamab monotherapy in this population of patients ? How anticipate the efficacy of subsequent systemic therapies ?\n\nAfter this information session, the participant will be asked to sign the study informed consent. A blood samples (2\\*10 mL on ethylenediaminetetraacetic acid (EDTA)) will be taken at time of disease progression and will be sent for central liquid biopsy ctDNA analysis. If available, tumor tissue will also be sent for DNA NGS analysis.",[58,59],"Non-small Cell Lung Cancer","EGFR Exon 20 Insertion Mutation",{"date":35,"type":36},{"date":62,"type":36},"2024-01-15",{"date":64,"type":21},"2026-07-30",{"name":42,"class":43},18,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100448695","analysis-of-biological-characteristics-of-advanced-alk-rearranged-nsclc-100448695","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",{"count":76,"type":21},100,[55],"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.",[58,80],"ALK Gene Rearrangement Positive",{"date":35,"type":36},{"date":83,"type":36},"2021-09-22",{"date":85,"type":21},"2027-06-30",{"name":42,"class":43},46,""]