[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06448754":3,"trial-entities:NCT06448754":488,"trial-summary:NCT06448754":493},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":58,"secondary_outcomes":67,"sex":94,"minimum_age":95,"maximum_age":96,"healthy_volunteers":15,"eligibility_criteria":97,"std_ages":115,"locations":118,"central_contacts":484,"overall_officials":485,"references":486,"see_also_links":487},"NCT06448754","D798KC00001","Volrustomig Priming Regimens Exploratory Phase II Platform Study","A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)","ACTIVE_NOT_RECRUITING","2027-07-30","2026-08","2026-08-31","2024-08-27","AstraZeneca","INDUSTRY",false,"Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.","This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types.\n\nThis platform study currently includes 2 substudies:\n\nSubstudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \\[NSQ\\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B.\n\nSubstudy 2: mNSCLC (squamous \\[SQ\\] or NSQ). Participants will enroll to the Arm 2A only.\n\nAll arms will test a volrustomig dosing in combination with chemotherapy.",[19],"Non-small Cell Lung Cancer",[21,22,23],"Solid Tumor","Programmed cell death-ligand-1","Tumor proportion score","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},194,"ACTUAL",[32,42,46,50,54],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":40},"DRUG","Volrustomig","Participants will receive volrustomig via intravenous (IV) infusion.",[37,38,39],"Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed","Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed","Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel",[41],"MEDI5752",{"type":33,"name":43,"description":44,"armGroupLabels":45},"Carboplatin","Participants will receive carboplatin via IV infusion.",[37,38,39],{"type":33,"name":47,"description":48,"armGroupLabels":49},"Pemetrexed","Participants will receive pemetrexed via IV infusion.",[37,38,39],{"type":33,"name":51,"description":52,"armGroupLabels":53},"Ramucirumab","Participants will receive ramucirumab via IV infusion.",[39],{"type":33,"name":55,"description":56,"armGroupLabels":57},"Paclitaxel","Participants will receive paclitaxel via IV infusion.",[39],[59,63],{"measure":60,"description":61,"timeFrame":62},"Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)","The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.","From screening (Days -28 to Day -1) up to 2 year 10 months",{"measure":64,"description":65,"timeFrame":66},"Confirmed Objective Response rate (ORR)","ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).","Up to 2 year 10 months",[68,71,74,77,80,83,86,88,91],{"measure":69,"description":70,"timeFrame":66},"Disease Control Rate (DCR)","DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.",{"measure":72,"description":73,"timeFrame":66},"Duration of Response (DOR)","DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).",{"measure":75,"description":76,"timeFrame":66},"Progression Free Survival (PFS)","PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).",{"measure":78,"description":79,"timeFrame":66},"Overall Survival (OS)","OS is defined as the time from randomization or first dose until the date of death due to any cause.",{"measure":81,"description":82,"timeFrame":66},"Serum Concentration of Volrustomig","The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.",{"measure":84,"description":85,"timeFrame":66},"Trough concentration (Ctrough)","The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.",{"measure":87,"description":82,"timeFrame":66},"Maximum Observed Concentration (Cmax)",{"measure":89,"description":90,"timeFrame":66},"Area Under the Curve (AUC)","The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.",{"measure":92,"description":93,"timeFrame":66},"Number of Participants with Positive Antidrug Antibodies (ADAs)","The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.","ALL","18 Years","130 Years",{"inclusion":98,"exclusion":107,"raw_text":114},[99,100,101,102,103,104,105,106],"Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration.","Life expectancy greater than or equal to (\\>=) 12 weeks.","Adequate organ and bone marrow function.","Body weight greater than (\\>) 35 kilograms (kg) at screening and at randomization.","Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2.","Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.","Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.","At least one measurable lesion not previously irradiated that can be accurately measured at baseline as \\>= 10 millimeter (mm) in the longest diameter.",[108,109,110,111,112,113],"Spinal cord compression.","History of primary active immunodeficiency.","Active or prior documented autoimmune or inflammatory disorders.","Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.","Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.","Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (\\>) 12 months from end of last therapy.","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration.\n* Life expectancy greater than or equal to (\\>=) 12 weeks.\n* Adequate organ and bone marrow function.\n* Body weight greater than (\\>) 35 kilograms (kg) at screening and at randomization.\n* Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2.\n* Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.\n* Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.\n* At least one measurable lesion not previously irradiated that can be accurately measured at baseline as \\>= 10 millimeter (mm) in the longest diameter.\n\nKey Exclusion Criteria:\n\n* Spinal cord compression.\n* History of primary active immunodeficiency.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.\n* Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.\n* Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (\\>) 12 months from end of last therapy.",[116,117],"ADULT","OLDER_ADULT",[119,128,135,142,148,154,160,166,173,179,185,191,198,204,207,210,213,216,223,226,229,235,241,248,254,260,266,272,278,284,290,296,303,309,315,322,325,328,334,341,347,353,360,367,373,379,386,392,398,404,410,416,422,428,434,437,444,450,456,462,469,475,481],{"facility":120,"city":121,"state":122,"zip":123,"country":124,"geoPoint":125},"Research Site","Los Angeles","California","90067","United States",{"lat":126,"lon":127},34.05223,-118.24368,{"facility":120,"city":129,"state":130,"zip":131,"country":124,"geoPoint":132},"Chapel Hill","North 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Compostela","15706",{"lat":426,"lon":427},42.88052,-8.54569,{"facility":120,"city":429,"zip":430,"country":382,"geoPoint":431},"Valencia","46015",{"lat":432,"lon":433},39.47391,-0.37966,{"facility":120,"city":429,"zip":435,"country":382,"geoPoint":436},"46026",{"lat":432,"lon":433},{"facility":120,"city":438,"zip":439,"country":440,"geoPoint":441},"Geneva","1205","Switzerland",{"lat":442,"lon":443},46.20222,6.14569,{"facility":120,"city":445,"zip":446,"country":440,"geoPoint":447},"Lausanne","1011",{"lat":448,"lon":449},46.516,6.63282,{"facility":120,"city":451,"zip":452,"country":440,"geoPoint":453},"Winterthur","8401",{"lat":454,"lon":455},47.50564,8.72413,{"facility":120,"city":457,"zip":458,"country":440,"geoPoint":459},"Zurich","8091",{"lat":460,"lon":461},47.36667,8.55,{"facility":120,"city":463,"zip":464,"country":465,"geoPoint":466},"Changhua","50006","Taiwan",{"lat":467,"lon":468},24.0692,120.5512,{"facility":120,"city":470,"zip":471,"country":465,"geoPoint":472},"New Taipei City","23561",{"lat":473,"lon":474},25.06199,121.45703,{"facility":120,"city":476,"zip":477,"country":465,"geoPoint":478},"Taipei","106",{"lat":479,"lon":480},25.05306,121.52639,{"facility":120,"city":476,"zip":482,"country":465,"geoPoint":483},"110",{"lat":479,"lon":480},[],[],[],[],{"nct_id":4,"conditions":489,"biomarkers":492},[490,491],"Lung Non-Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":494,"summary":495,"prompt_version":505},true,{"design":496,"status":497,"heading":498,"summary":499,"follow_up":500,"word_count":501,"commitments":502,"compensation":503,"drugs_mentioned":504},"This is an open-label, multi-center Phase 2 study, meaning both you and your doctors will know which treatments you are receiving. It is a platform study with two substudies, and participants will be randomized into different treatment arms.","completed","Phase 2 Volrustomig for Non-Small Cell Lung Cancer","This study is testing a new drug called volrustomig in combination with other cancer medications like carboplatin, pemetrexed, ramucirumab, and paclitaxel for people with non-small cell lung cancer. Researchers want to see how safe these combinations are, how well your body handles them, and if they can shrink tumors. You might be able to join if you are 18 or older, have a good general health status (ECOG performance status of 0 or 1), a life expectancy of at least 12 weeks, and adequate organ function. The study aims to enroll 180 participants, but its current recruitment status is unclear.","Participants will be followed for adverse events and serious adverse events for up to 2 years and 10 months. Tumor response will also be measured for up to 2 years and 10 months.",100,"Not specified in the trial record.","Not stated in the trial record.",[34,43,47,51,55],"v2"]