[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561046":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":19,"overallStatus":68,"whyStopped":19,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB2928 injection + Almonertinib Mesilate Tablets","EXPERIMENTAL","Every 3 weeks constitutes one treatment cycle. For the first 2 cycles, TQB2928 is administered via infusion once a week. Starting from the 3rd cycle, TQB2928 is administered once every 3 weeks. Amivantamab is taken orally at a fixed time daily.",[13],"Drug: TQB2928 injection + Almonertinib Mesilate Tablets",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","TQB2928 is a recombinant fully humanized Immunoglobulin G4 (IgG4) monoclonal antibody that can promote tumor cell phagocytosis by macrophages and exert anti-tumor effects.\n\nAlmonertinib Mesilate Tablets is a third generation of EGFR-TKI targeting drug.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Li Zhang, Doctor","CONTACT","020-87343458","Zhangli@syscc.cn",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Wenfeng Fang, Doctor","15322302066","fangwf@sysucc.org.cn",[31],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.25,23.11667,{"lat":42,"lon":41},[45,46],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100561046","phase-1-clinical-trial-of-tqb2928-in-combination-with-a-third-generation-epidermal-growth-factor-receptor-egfr-tyrosine-kinase-inhibitor-tki-in-patients-with-advanced-non-small-cell-lung-cancers-100561046",false,"NCT06585059","Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers","A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers","Inclusion Criteria:\n\n* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；\n* Locally advanced or metastatic NSCLC diagnosed by histology or cytology\n* The major organs are functioning well；\n* Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；\n* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.\n\nExclusion Criteria:\n\n* Current concomitant presence of other malignancies within 5 years prior to the first dose;\n* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;\n* Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures;\n* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;\n* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;\n* Subjects with any severe and\u002For uncontrolled disease;\n* History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;\n* Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;\n* According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.","ALL","18 Years","75 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).",[67],"Advanced Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2024-09-03",{"date":71,"type":72},"2024-09-05","ACTUAL",{"date":74,"type":61},"2024-09",{"date":76,"type":61},"2026-12",{"name":78,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",1]