[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632742":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":56,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":22,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":22,"enrollmentInfo":68,"targetDuration":22,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":22,"overallStatus":77,"whyStopped":22,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Local therapy","EXPERIMENTAL","Subjects will receive ablation or stereotactic body radiotherapy, followed by sequential treatment with furmonertinib for 3 years.\n\nDosing regimen: furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years.",[13,14,15],"Drug: furmonertinib","Procedure: ablation","Radiation: stereotactic body radiotherapy",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","furmonertinib","furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"PROCEDURE","ablation","1. Immobilization and image guidance: Supine or prone position; vacuum cushion or mask to limit motion. CT guidance for entry point, angle, and depth; ultrasound for selected peripheral lesions.\n2. Ablation target planning: Ablation zone should cover GTV with ≥5-10 mm margin. For tumors near critical structures, pursue adequate margin when safe; consider heat sink or thermal isolation.\n3. Ablation procedure: Choose MWA, RFA, or cryoablation based on tumor size, location, anatomy, and resources.\n4. Intraprocedural monitoring and endpoint assessment: CT during\u002Fafter ablation to confirm ground-glass opacity covers tumor with planned margin. Ablation zone ≥5 mm beyond tumor = technical success. If inadequate, reposition and supplement.\n5. Post-procedure management and follow-up: Monitor vital signs; manage complications as needed.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"RADIATION","stereotactic body radiotherapy","1. Immobilization: Use a thermoplastic mask or vacuum cushion for immobilization based on the treatment site.\n2. CT simulation: After immobilization and stabilization of breathing, laser alignment is performed, followed by 4D-CT simulation (preferred) or conventional CT simulation.\n3. Radiotherapy target delineation and dose: GTV includes the primary lung tumor and metastatic lymph nodes after chemotherapy. A 5-mm margin is added to form the PTV.\n4. Radiotherapy plan: For peripheral lesions: 48 Gy in 4 fractions or 50 Gy in 5 fractions; for central lesions: 60 Gy in 8 fractions or 60 Gy in 10 fractions.",[9],[34],{"name":35,"affiliation":5,"role":36},"Xuefei Hu","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Chang Chen","CONTACT","+86 21 65115006","shsfkyy@126.com",[44],{"facility":45,"status":22,"city":46,"state":22,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":22},"Shanghai Pulmonary Hospital","Shanghai","200433","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},{"type":57,"investigatorFullName":35,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Chief Physician","100632742","phase-2-combining-furmonertinib-with-local-therapy-for-inoperable-early-stage-lung-cancer-a-phase-ii-trial-100632742",false,"NCT07517640","Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial","Furmonertinib Combined With Local Therapy in Inoperable or Surgery-Refusing Early-Stage Non-Small Cell Lung Cancer:A Single-arm, Phase II Study","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study\n* Aged ≥ 18 years at the time of signing the informed consent form\n* Histologically or cytologically confirmed early-stage T1-3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence\n* Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations\n* ECOG performance status score of 0-2\n* Deemed medically inoperable or refuse surgery after multidisciplinary evaluation\n* Pulmonary lesions suitable for ablation or radiotherapy (either modality)\n* Adequate major organ function\n\nExclusion Criteria:\n\n* Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug\n* Known contraindications to ablation or radiotherapy\n* Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan\n* Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose\n* Patients with hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus \\[HCV\\] antibody positive and detectable HCV-RNA indicating viral replication)\n* Receipt of curative-intent radiotherapy within 3 months prior to the first dose\n* Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered)\n* Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study","ALL","18 Years",{"count":69,"type":70},45,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery.\n\nThe main purposes of this study is to answer:\n\nCan ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?",[76],"Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-03-31",{"date":80,"type":81},"2026-04-08","ACTUAL",{"date":83,"type":70},"2026-04-01",{"date":85,"type":70},"2028-08-31",{"name":5,"class":6},1]