Nctid:
NCT06232265
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"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"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Non-small Cell 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"=>{"browseLeaves"=>[{"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>108}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-09-22", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-08-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Objective Response Rate (ORR)", "timeFrame"=>"3 years", "description"=>"Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)"}], "secondaryOutcomes"=>[{"measure"=>"Progression-free Survival (PFS)", "timeFrame"=>"3 years", "description"=>"Defined as the time from first recieving treatment to the first occurrence of disease progression or death from any cause determined by IRC based on the Solid Tumor Efficacy Evaluation Criteria (RECIST) 1.1, whichever occurs first"}, {"measure"=>"Overall Survival (OS)", "timeFrame"=>"3 years", "description"=>"Defined as the time from first treatment to death for any reason."}, {"measure"=>"Duration of response (DoR)", "timeFrame"=>"3 years", "description"=>"Defined as the time from the first recorded objective remission to the disease progression determined by IRC according to RECIST version 1.1, or the time of death from any cause, whichever occurs first."}, {"measure"=>"Disease Control Rate (DCR)", "timeFrame"=>"3 years", "description"=>"Defined as the proportion of patients whose best overall efficacy (BOR) determined by IRC according to RECIST 1.1 is complete remission, partial remission, or disease stability"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["immunotherapy", "LIRA score", "biomarker"], "conditions"=>["Non-small Cell Lung Cancer"]}, "descriptionModule"=>{"briefSummary"=>"This is a multi-center, observational clinical study to explore the role of LIRAscore in predicting immunotherapy monotherapy and combination with chemotherapy efficacy and prognosis in locally advanced or metastatic non-small-cell lung cancer. The study plans to enroll 108 patients. The primary endpoint of this study was ORR, and secondary endpoints were PFS, OS, DoR, DCR, and safety."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"The subjects of this study were patients with previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patients voluntarily participated in the study, signed the informed consent, and had good compliance;\n2. Histologically and/or cytologically confirmed previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation;\n3. Patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy;\n4. The patient agrees to provide the remaining tissue samples after clinical routine diagnosis during the baseline period for LIRA score and PD-L1 immunohistochemical testing;\n5. The Eastern Organization for Oncology (ECOG) physical fitness score is 0 or 1;\n6. The patient has at least one measurable or unmeasurable but evaluable lesion.\n\nExclusion Criteria:\n\n1. According to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment;\n2. Patients with known EGFR mutations, ALK rearrangements or ROS1 rearrangements are not eligible to participate in this study;\n3. According to the researcher's judgment, the patient is not suitable to participate in this study."}, "identificationModule"=>{"nctId"=>"NCT06232265", "briefTitle"=>"An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore", "organization"=>{"class"=>"OTHER", "fullName"=>"Nanfang Hospital, Southern Medical University"}, "officialTitle"=>"An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore", "orgStudyIdInfo"=>{"id"=>"NFEC-2023-412"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"510515", "city"=>"Guangzhou", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Wangjun Liao, MD, PhD", "role"=>"CONTACT", "email"=>"nfyyliaowj@163.com", "phone"=>"86-20-62787731"}, {"name"=>"Wangjun Liao, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Nanfang Hospital, Southern Medical University", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}], "centralContacts"=>[{"name"=>"Wangjun Liao, MD, PhD", "role"=>"CONTACT", "email"=>"nfyyliaowj@163.com", "phone"=>"86-20-62787731"}], "overallOfficials"=>[{"name"=>"Wangjun Liao, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Nanfang Hospital, Southern Medical University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Nanfang Hospital, Southern Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
