[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516179":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":28,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","Patients will receive cadonilimab (10mg\u002Fkg) plus pemetrexed(500mg\u002Fm2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg\u002Fkg) plus pemetrexed (500mg\u002Fm2) every 3 weeks as maintenance therapy.",[13,14,15],"Drug: Cadonilimab","Drug: Pemetrexed","Drug: Carboplatin",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cadonilimab","Patients receive cadonilimab (10mg\u002Fkg) every 3 weeks.",[9],[23],"AK104",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Pemetrexed","Patients receive pemetrexed (500mg\u002Fm2) every 3 weeks.",[9],null,{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Carboplatin","Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.",[9],[34],{"name":35,"affiliation":5,"role":36},"Qian Chu","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","13212760751","+86","qianchu@tjh.tjmu.edu.cn",[44],{"facility":35,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":52,"coordinates":53},"Point",[54,55],114.26667,30.58333,{"lat":55,"lon":54},[58],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":60,"investigatorFullName":35,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Professor",[63],{"name":64,"class":6},"Akeso Pharmaceuticals, Inc.","100516179","phase-2-cadonilimab-ak104-plus-chemotherapy-as-first-line-treatment-in-non-squamous-non-small-cell-lung-cancer-nsclc-patients-with-programmed-cell-death-ligand-1-pd-l1-negative-100516179",false,"NCT06001151","Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative","Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative：A Multi-center, Single-arm, Phase II Study","ACHELOUS","Inclusion Criteria:\n\n* Patients with histologically\u002Fcytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)\n* PD-L1 TPS\\\u003C1%\n* Life expectancy more than 3 months\n* Without EGFR-sensitive mutation (19Exon del\u002F21Exon L858R), ALK, ROS1 gene rearrangement or fusion\n* Has no prior systemic therapy; (chemotherapy and\u002For radiotherapy is allowed as part of neoadjuvant\u002Fadjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant\u002Fadjuvant treatment would be enrolled)\n* ECOG score 0-1\n* Patients must have at least one measurable lesion according to RECIST 1.1\n* Has adequate organ function\n* Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)\n* Voluntarily sign a written informed consent form\n\nExclusion Criteria:\n\n* Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer\n* With active central nervous system (CNS) metastases confirmed by CT or MRI\n* With other malignancy within 3 years before enrollment\n* With severe infections within 4 weeks of the first dose of study treatment\n* Women who are pregnant or lactating\n* History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy\n* History of myocarditis, cardiomyopathy, and malignant arrhythmia\n* Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.\n* Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction\n* Active autoimmune diseases that require systematic treatment within 2 years before enrollment\n* History of Human Immunodeficiency Virus (HIV)\n* With active hepatitis B infection\n* With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage","ALL","18 Years","75 Years",{"count":77,"type":78},49,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1\u002FCTLA-4 bi-specific antibody.",[84],"Carcinoma, Non-Small-Cell Lung",[86,87,88],"non-squamous Non-Small Cell Lung Cancer","Programmed Cell Death Ligand 1","cadonilimab","2023-08-18",{"date":91,"type":92},"2023-08-21","ACTUAL",{"date":94,"type":92},"2023-08-07",{"date":96,"type":78},"2027-08-31",{"name":35,"class":6},1]