Nctid:
NCT06234579
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}, {"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"NSCLC", "relevance"=>"HIGH"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11172", "name"=>"Lung Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000582670", "term"=>"Alectinib"}], "ancestors"=>[{"id"=>"D000092004", "term"=>"Tyrosine Kinase Inhibitors"}, {"id"=>"D000047428", "term"=>"Protein Kinase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M145666", "name"=>"Alectinib", "asFound"=>"Calcium carbonate", "relevance"=>"HIGH"}, {"id"=>"M2889", "name"=>"Tyrosine Kinase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M25820", "name"=>"Protein Kinase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"T22", "name"=>"Tyrosine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"At the time of diagnosis, all newly diagnosed ALK+ NSCLC patients eligible for first line treatment with alectinib or brigatinib or lorlatinib will be considered for the study.\n\nIn case of progression, a multidisciplinary team (oncologists, interventional pneumologists and radiologists, surgeons) will discuss case-by-case the feasibility to procure an adequate biopsy from progressing lesions. Repeat biopsies will be performed within 2 weeks from multidisciplinary evaluation and before the start of subsequent treatment. If repeat biopsies are not technically or safely feasible or fail to yield sufficient material for genomic analysis, we will collect a whole blood drawn by venepuncture for the analysis of ctDNA."}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>108}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2021-07-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2026-07-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-29", "studyFirstSubmitDate"=>"2023-04-10", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-03-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"PFS to first-line treatment with II-III generation ALK-inhibitor", "timeFrame"=>"Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years", "description"=>"PFS to first-line, stratified according to ALK-rearrangement variants"}, {"measure"=>"PFS to first-line treatment with II-III generation ALK-inhibitor", "timeFrame"=>"Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years", "description"=>"PFS to first-line, stratified according to NGS-based mutational profiling"}, {"measure"=>"OS to first-line treatment with II-III generation ALK-inhibitor", "timeFrame"=>"Time from treatment start until the date of death from any cause, assessed up to 5 years", "description"=>"OS to first-line, stratified according to ALK-rearrangement variants"}, {"measure"=>"OS to first-line treatment with II-III generation ALK-inhibitor", "timeFrame"=>"Time from treatment start until the date of death from any cause, assessed up to 5 years", "description"=>"OS to first-line, stratified according to NGS-based mutation profiling"}, {"measure"=>"Incidence of secondary resistance mutations (SNVs) after first line treatment", "timeFrame"=>"5 years", "description"=>"Percentage of patients with SNV-based resistance diagnosed by tissue or liquid biopsy"}, {"measure"=>"PFS to lorlatinib according to secondary resistance mechanism", "timeFrame"=>"Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years", "description"=>"PFS to second-line lorlatinib, stratified according to type of resistance (SNV vs off-target)"}], "primaryOutcomes"=>[{"measure"=>"Percentage of patients with available NGS testing at diagnosis", "timeFrame"=>"5 years", "description"=>"Percentage of ALK+ patients with adeguate tissue for NGS after diagnosisc biopsy"}, {"measure"=>"Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor", "timeFrame"=>"5 years", "description"=>"Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy"}], "secondaryOutcomes"=>[{"measure"=>"PFS to first-line treatment with II-III generation ALK-inhibitor", "timeFrame"=>"5 years", "description"=>"Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years"}, {"measure"=>"PFS to first-line treatment with II-III generation ALK-inhibitor", "timeFrame"=>"5 years", "description"=>"Time from treatment start to death for any cause, assesed up to 5 years"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["ALK mutation", "NSCLC"], "conditions"=>["ALK Gene Mutation", "NSCLC Stage IV", "ALK Sensitizing Mutation"]}, "descriptionModule"=>{"briefSummary"=>"The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with newly diagnosed ALK+ NSCLC who are candidate to receive first-line therapy with II-III genaration ALK-inhibitor (alectinib, brigatinib or lorlatinib)", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available)\n\n b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days\n\n c) ECOG PS 0-2\n\n d) adult patients (aged ≥ 18 years) at the moment of diagnosis\n\n e) signing of informed consent approved by the local Ethic Committee\n\nExclusion Criteria:\n\na) Diagnosis of lung cancer without ALK rearrangement\n\na) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study"}, "identificationModule"=>{"nctId"=>"NCT06234579", "acronym"=>"GALILEO", "briefTitle"=>"Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)", "organization"=>{"class"=>"OTHER", "fullName"=>"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"}, "officialTitle"=>"\"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate\".", "orgStudyIdInfo"=>{"id"=>"4906"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"ALK+ NSCLC", "description"=>"The GALILEO project is an Italian observational prospective cohort study on advanced ALK+ NSCLC patient progressing on first-line therapy with alectinib", "interventionNames"=>["Diagnostic Test: Biopsy (tissue or liquid)"]}], "interventions"=>[{"name"=>"Biopsy (tissue or liquid)", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["Alectinib", "Brigatinib", "Lorlatinib"], "description"=>"At the time of diagnosis, all newly diagnosed ALK+ NSCLC patients eligible for first line treatment with alectinib or brigatinib or lorlatinib will be considered for the study.\n\nIn case of progression, a multidisciplinary team (oncologists, interventional pneumologists and radiologists, surgeons) will discuss case-by-case the feasibility to procure an adequate biopsy from progressing lesions. Repeat biopsies will be performed within 2 weeks from multidisciplinary evaluation and before the start of subsequent treatment. If repeat biopsies are not technically or safely feasible or fail to yield sufficient material for genomic analysis, we will collect a whole blood drawn by venepuncture for the analysis of ctDNA.", "armGroupLabels"=>["ALK+ NSCLC"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"00168", "city"=>"Rome", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Emilio Bria, Professor", "role"=>"CONTACT", "email"=>"emilio.bria@policlinicogemelli.it", "phone"=>"0630155202", "phoneExt"=>"+39"}], "facility"=>"Fondazione Policlinico Gemelli IRCCS", "geoPoint"=>{"lat"=>41.89193, "lon"=>12.51133}}], "centralContacts"=>[{"name"=>"Emanuele Vita, MD", "role"=>"CONTACT", "email"=>"dr.emanuele.vita@gmail.com", "phone"=>"3480510228"}, {"name"=>"EMILIO Bria, Prof.", "role"=>"CONTACT", "email"=>"emilio.bria@policlinicogemelli.it", "phone"=>"0630156318"}], "overallOfficials"=>[{"name"=>"GIAMPAOLO TORTORA, Prof.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Fondazione Policlinico Universitario A Gemelli"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof.", "investigatorFullName"=>"Bria Emilio", "investigatorAffiliation"=>"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"}}}}
