[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647554":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":142,"collaborators":144,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":19,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":19,"enrollmentInfo":156,"targetDuration":19,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":19,"overallStatus":165,"whyStopped":19,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Abbisko Therapeutics Co, Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ABSK043 in combination with Osimertinib","EXPERIMENTAL","This is an open-label phase 2 study with an escalation part and an expansion part.",[13],"Drug: ABSK043 in combination with Osimertinib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Three potential dose levels of ABSK043 are prespecified, and Osimertinib will be administered orally at a fixed dose of 80 mg QD in escalation cohort.\n\nPatients in dose confirmation cohort and dose expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity of the combination therapy.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Zan Chen","CONTACT","+8613816094024","zan.chen@abbisko.com",[27,46,62,79,96,112,128],{"facility":28,"status":19,"city":29,"state":30,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong","China","CN",{"type":34,"coordinates":35},"Point",[36,37],113.25,23.11667,{"lat":37,"lon":36},[40,44],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Kejing Tang, Doctor","+8620-87755766","tangkejing@163.com",{"name":41,"role":45,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"facility":47,"status":19,"city":48,"state":49,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang",{"type":34,"coordinates":51},[52,53],126.65,45.75,{"lat":53,"lon":52},[56,61],{"name":57,"role":23,"phone":58,"phoneExt":59,"email":60},"Yanbin Zhao, Doctor","+86451-86298000","+8613904811741","zhaoyb_gcp@126.com",{"name":57,"role":45,"phone":19,"phoneExt":19,"email":19},{"facility":63,"status":19,"city":64,"state":65,"zip":66,"country":31,"countryCode":32,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430022",{"type":34,"coordinates":68},[69,70],114.26667,30.58333,{"lat":70,"lon":69},[73,78],{"name":74,"role":23,"phone":75,"phoneExt":76,"email":77},"Xiaorong Dong, Doctor","+8627-85728022","+8613986252286","xhzzdxr@126.com",{"name":74,"role":45,"phone":19,"phoneExt":19,"email":19},{"facility":80,"status":19,"city":81,"state":82,"zip":83,"country":31,"countryCode":32,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"The First Hospital of China Medical University","Shenyang","Liaoning","110001",{"type":34,"coordinates":85},[86,87],123.43278,41.79222,{"lat":87,"lon":86},[90,95],{"name":91,"role":23,"phone":92,"phoneExt":93,"email":94},"Mingfang Zhao, Doctor","+8624-83282888","+8613644055129","zhaomf618@126.com",{"name":91,"role":45,"phone":19,"phoneExt":19,"email":19},{"facility":97,"status":19,"city":98,"state":99,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality",{"type":34,"coordinates":101},[102,103],121.45806,31.22222,{"lat":103,"lon":102},[106,111],{"name":107,"role":23,"phone":108,"phoneExt":109,"email":110},"Shun Lu, Doctor","+8621-62821990","+8613601813062","shunlu_shchest@sina.com",{"name":107,"role":45,"phone":19,"phoneExt":19,"email":19},{"facility":113,"status":19,"city":114,"state":115,"zip":116,"country":31,"countryCode":32,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Shanxi Provincial Cancer Hospital","Taiyuan","Shanxi","030013",{"type":34,"coordinates":118},[119,120],112.56028,37.86944,{"lat":120,"lon":119},[123,127],{"name":124,"role":23,"phone":125,"phoneExt":19,"email":126},"Wei Guo, Doctor","+86351-4881611","guowei812@126.com",{"name":124,"role":45,"phone":19,"phoneExt":19,"email":19},{"facility":129,"status":19,"city":130,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou",{"type":34,"coordinates":132},[133,134],120.16142,30.29365,{"lat":134,"lon":133},[137,141],{"name":138,"role":23,"phone":139,"phoneExt":19,"email":140},"Jianying Zhou, Doctor","+86571-87236876","drzjy@163.com",{"name":138,"role":45,"phone":19,"phoneExt":19,"email":19},{"type":143,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[145],{"name":146,"class":6},"AstraZeneca","100647554","phase-2-a-phase-2-study-of-absk043-combined-with-osimertinib-100647554",false,"NCT07710612","A Phase 2 Study of ABSK043 Combined With Osimertinib","A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria：\n\n1. Aged 18 or above, male or female.\n2. Participants must understand and voluntarily participate in this study and must have been provided informed consent for study participation.\n3. NSNLC confirmed by tissue or cytological pathology. NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology.\n4. Diagnosed locally advanced or metastatic NSCLC\n5. Different requirements for specific cohort:\n\n   Dose escalation and backfill cohorts:\n   1. Participants with disease in the adjuvant setting, post chemoradiotherapy setting, locally advanced stage or metastatic stage, who have received at least one prior line of third-generation EGFR-TKI-based monotherapy or combination therapy and experienced disease progression.\n   2. Participants must have received ≥2 prior lines of frontline systemic therapy.\n   3. Documented or central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS\u002FTC≥1%).\n   4. Documented genetic testing report confirms the presence of EGFR alteration(s) in tumor or plasma.\n\n   Expansion cohort(s):\n   1. Participants must not have received any other prior systemic cancer therapies in the locally advanced\u002Fmetastatic setting for locally advanced or metastatic disease.\n   2. Central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS\u002FTC≥1%).\n   3. Documented genetic testing reports confirm the presence of EGFR\n6. Presence of at least one measurable tumor lesion\n7. ECOG score 0-1 at screening.\n8. The expected life expectancy after the first dose is \\>12 weeks.\n\nExclusion Criteria:\n\n* 1\\. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.\n\n  2\\. Has a history of interstitial lung disease (ILD)\u002Fpneumonitis or active ILD 3. Spinal cord compression and unstable brain metastases. 4.Any unresolved toxicities from prior systemic therapy greater than CTCAE v6.0 Grade 1 at the time of starting study treatment.\n\n  5\\. Participants with obvious and unstable pleural effusion, peritoneal effusion or pericardial effusion .\n\n  6\\. Has a history of other malignant tumors, or currently have other malignant tumors.\n\n  7\\. Participants with known HIV infection.","ALL","18 Years",{"count":157,"type":158},72,"ESTIMATED","INTERVENTIONAL",[161],"PHASE2","This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer",[164],"Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive","NOT_YET_RECRUITING","2026-07-14",{"date":168,"type":169},"2026-07-17","ACTUAL",{"date":171,"type":158},"2026-08-31",{"date":173,"type":158},"2030-12-31",{"name":5,"class":6},7]