Nctid:
NCT06613633
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008175", "term"=>"Lung Neoplasms"}, {"id"=>"D002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"id"=>"D012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Non-small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "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"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000596361", "term"=>"Osimertinib"}, {"id"=>"C000705711", "term"=>"Aflutinib"}], "ancestors"=>[{"id"=>"D000092004", "term"=>"Tyrosine Kinase Inhibitors"}, {"id"=>"D047428", "term"=>"Protein Kinase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M145673", "name"=>"Osimertinib", "asFound"=>"Atopic", "relevance"=>"HIGH"}, {"id"=>"M352860", "name"=>"Aflutinib", "asFound"=>"Laughter", "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"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>4000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2018-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2024-09-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-10-29", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Time to Best Response", "timeFrame"=>"5 years", "description"=>"The time from the first day of third-generation EGFR-TKI treatment to the point at which the smallest tumor burden is observed on imaging studies."}], "secondaryOutcomes"=>[{"measure"=>"Distribution of Tumor Lesions at Best Response", "timeFrame"=>"5 years", "description"=>"the distribution of tumor lesions at the time when the smallest tumor burden is observed on imaging. Focus on whether the remaining lesions are suitable for consolidative stereotactic radiotherapy, per the relevant criteria endorsed by the NRG-BR001 study."}, {"measure"=>"Phenotypes of Disease Progression After Third-Generation EGFR-TKI Resistance", "timeFrame"=>"5 years", "description"=>"Tumor distribution when disease progression occurs during third-generation EGFR-TKI treatment (disease progression is defined by RECIST 1.1 criteria). The pattern of progressive disease will be classified into the following three types based on imaging assessment:\n\n1. Original Site Failure (OF): Progression of lesions that were present at baseline (enlargement of existing lesions).\n2. Distant Site Failure (DF): New tumor lesions occurring in areas where no lesions were present at baseline.\n3. Original and Distant site failure (ODF): The coexistence of the two situations mentioned above."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["NSCLC", "EGFR"], "conditions"=>["Third-generation TKI", "NSCLC (Advanced Non-small Cell Lung Cancer)"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance.\n\nIn summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Advanced EGFR-mutant NSCLC patients receiving third-generation EGFR-TKIs are enrolled", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Pathologically confirmed non-small cell lung cancer;\n* clinical stage IV (AJCC, 8th edition, 2017);\n* EGFR sensitizing mutations (L858R or 19del);\n* age≥18 years old;\n* KPS score≥70;\n* complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;\n* received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);\n* willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;\n* informed consent of the patient.\n\nExclusion Criteria:\n\n* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);\n* Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;\n* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;\n* patients without EGFR sensitive mutations or with unknown EGFR mutation status.\n\nWithdrawal criteria\n\n* The investigators considered that the patients had poor adherence to the study protocol.\n* The patient withdrew informed consent and asked to withdraw.\n* There was any safety reason (adverse event) considered by the investigator;\n* Due to other underlying diseases, side effects, economic factors, and other reasons, patients did not receive regular doses of third-generation EGFR-TKI (continuous withdrawal time more than 1 week, cumulative withdrawal time more than 2 weeks, etc.).\n* The patient was not followed up according to the protocol.\n* Other circumstances in which withdrawal from the study was deemed necessary by the investigator."}, "identificationModule"=>{"nctId"=>"NCT06613633", "briefTitle"=>"Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC", "organization"=>{"class"=>"OTHER", "fullName"=>"Fudan University"}, "officialTitle"=>"Pattern of Failure and Feasibility of Consolidative Stereotactic Radiotherapy in Third-generation EGFR-TKI-treated Metastatic EGFR-mutant Non-small Cell Lung Cancer: A Prospective, Observational Study", "orgStudyIdInfo"=>{"id"=>"2018-NSCLCSIB"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"third-generation EGFR-TKI monotherapy", "interventionNames"=>["Drug: third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)"]}], "interventions"=>[{"name"=>"third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)", "type"=>"DRUG", "description"=>"Patients with advanced EGFR-mutated NSCLC who met the inclusion criteria and received third-generation EGFR-TKI (monotherapy or combined with brain radiotherapy)", "armGroupLabels"=>["third-generation EGFR-TKI monotherapy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200050", "city"=>"Shanghai", "state"=>"Shanghai", "country"=>"China", "facility"=>"Shanghai Cancer Center", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fudan University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Zhengfei Zhu", "investigatorAffiliation"=>"Fudan University"}}}}
