Nctid:
NCT06617416
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"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>560}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2028-12-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-28", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Progression-free survival (PFS) assessed by INV", "timeFrame"=>"3 years", "description"=>"PFS is defined as the time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1)."}], "secondaryOutcomes"=>[{"measure"=>"OS", "timeFrame"=>"5 years", "description"=>"Time from randomization to death"}, {"measure"=>"6-month PFS rate assessed by INV", "timeFrame"=>"3 years", "description"=>"PFS rate at 6 months"}, {"measure"=>"AEs", "timeFrame"=>"3 years", "description"=>"Adverse events incidence and severity, clinically significant abnormal laboratory test results."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["NSCLC (Non-small Cell Lung Cancer)"]}, "descriptionModule"=>{"briefSummary"=>"This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Subjects must sign the written informed consent form (ICF) voluntarily.\n2. Age ≥18 years.\n3. Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.\n4. Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.\n5. Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.\n6. Chemotherapy regimens should be in accordance with current clinical guidelines.\n7. Consolidation chemotherapy is not allowed after radiotherapy.\n8. Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).\n9. No disease progression after concurrent or sequential chemoradiotherapy.\n10. ECOG performance status score of 0-1.\n11. Expected survival of over 3 months.\n12. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. The histopathology contains any component of small cell lung cancer.\n2. Currently participating in another interventional clinical study.\n3. Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.\n4. Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.\n5. Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.\n6. Tumor invades important vessels or organs.\n7. Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.\n8. Presence of interstitial lung disease that requires treatment.\n9. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).\n10. Experienced severe infection within 4 weeks prior to the first dose.\n11. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.\n12. Any condition that required systemic treatment with corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.\n13. Active autoimmune diseases or history of autoimmune diseases that may relapse.\n14. Previous history of severe hypersensitivity reactions to other monoclonal antibodies.\n15. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation."}, "identificationModule"=>{"nctId"=>"NCT06617416", "briefTitle"=>"A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Akeso"}, "officialTitle"=>"A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy", "orgStudyIdInfo"=>{"id"=>"AK104-309"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"AK104 group", "description"=>"AK104 Q3W", "interventionNames"=>["Drug: Cadonilimab (AK104)"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Sugemalimab group", "description"=>"Sugemalimab 1200mg Q3W", "interventionNames"=>["Drug: Sugemalimab"]}], "interventions"=>[{"name"=>"Cadonilimab (AK104)", "type"=>"DRUG", "description"=>"AK104 ivgtt Q3W", "armGroupLabels"=>["AK104 group"]}, {"name"=>"Sugemalimab", "type"=>"DRUG", "description"=>"1200mg Q3W", "armGroupLabels"=>["Sugemalimab group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Jinan", "country"=>"China", "contacts"=>[{"name"=>"Jinming Yu, MD", "role"=>"CONTACT", "email"=>"sdzlllh803@126.com", "phone"=>"+86-0531-87984777"}], "facility"=>"Cancer Hospital of Shandong First Medical University", "geoPoint"=>{"lat"=>36.66833, "lon"=>116.99722}}], "centralContacts"=>[{"name"=>"Ting Liu, MD", "role"=>"CONTACT", "email"=>"clinicaltrials@akesobio.com", "phone"=>"+86-0760-89873925"}], "overallOfficials"=>[{"name"=>"Jinming Yu, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Shandong Cancer Hospital and Institute"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Akeso", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
