[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621037":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":38,"locations":44,"responsibleParty":57,"collaborators":27,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":27,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":27,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":27,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Furmonertinib 160mg Group","EXPERIMENTAL","Participants receive oral furmonertinib 160mg once daily as first-line treatment.",[13],"Drug: Furmonertinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Furmonertinib 80mg + Chemotherapy Group","ACTIVE_COMPARATOR","Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.",[13,19,20],"Drug: carboplatin","Drug: pemetrexed",[22,28,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Furmonertinib","Oral administration, 160mg once daily.",[9],null,{"type":23,"name":24,"description":29,"armGroupLabels":30,"otherNames":27},"Oral administration, 80mg once daily",[15],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"carboplatin","Intravenous infusion, cycle-based (per study protocol).",[15],{"type":23,"name":36,"description":33,"armGroupLabels":37,"otherNames":27},"pemetrexed",[15],[39],{"name":40,"role":41,"phone":42,"phoneExt":27,"email":43},"Dingzhi Huang Huang","CONTACT","+86-22-23340123-1031","dingzhih72@163.com",[45],{"facility":5,"status":27,"city":46,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Tianjin","China","CN",{"type":50,"coordinates":51},"Point",[52,53],117.17667,39.14222,{"lat":53,"lon":52},[56],{"name":40,"role":41,"phone":42,"phoneExt":27,"email":43},{"type":58,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100621037","phase-2-furmonertinib-160mg-vs-80mg--chemotherapy-in-egfr-mutated-nsclc-with-brain-metastases-efficacy-and-safety-study-100621037",false,"NCT07365410","Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study","Furmonertinib 160mg Versus Furmonertinib 80mg Combined With Chemotherapy (Carboplatin + Pemetrexed) as First-Line Treatment for EGFR-Mutated NSCLC Patients With Brain Metastases: A Multicenter Study of Efficacy and Safety","IInclusion Criteria\n\n* Aged 18 to 75 years (male or female)\n* Histopathologically confirmed, unresectable, and non-radiocurable newly -diagnosed locally advanced or metastatic lung adenocarcinoma\n* Confirmed by local laboratory to have one of the following EGFR mutations: -19Del or L858R (single or mixed mutations are allowed)\n* Treatment-naive for locally advanced (not suitable for surgery\u002Fradiotherapy per investigator) or metastatic NSCLC; adjuvant\u002Fneoadjuvant therapy completed \\>6 months before first progression is allowed (≤6 months is considered pretreated)\n* At least one measurable tumor lesion per RECIST 1.1 (lesions previously treated with radiotherapy are excluded; if only one measurable lesion exists, biopsy is allowed but baseline imaging must be performed ≥14 days after biopsy)\n* Confirmed stable and asymptomatic brain metastases\n* Sufficient organ function (per laboratory tests): ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, HGB ≥90g\u002FL; TBIL ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (for liver metastasis: TBIL ≤3×ULN, AST\u002FALT ≤5×ULN); CrCL ≥50 ml\u002Fmin (Cockcroft-Gault formula)\n* ECOG performance status 0-2 (no significant disease deterioration in 2 weeks before screening)\n* Expected survival \\>12 weeks after first dose\n* Non-pregnant women of childbearing potential (no pregnancy plan); women and men agree to use effective contraception during the study and 6 months after drug discontinuation\n* Voluntarily signs informed consent and understands the study procedures Exclusion Criteria（排除标准）\n* NSCLC with predominantly squamous cell histology, small cell lung cancer, neuroendocrine carcinoma, or other non-adenocarcinoma histologies\n* Concurrent positive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation); TP53, RB1, and BRAC mutations are excluded\n* Expected to receive other anti-tumor therapies during the trial\n* Major surgery (except vascular access or biopsy) within 4 weeks before first dose or planned during the trial\n* Use of CYP3A4 strong inhibitor within 7 days or strong inducer within 21 days before first dose; use of anti-tumor Chinese medicine within 2 weeks before first dose or planned during the trial\n* Participation in other clinical trials (investigational drug\u002Fdevice) within 4 weeks or 5 half-lives before first dose\n* Use of other anti-tumor drugs within 14 days before first dose\n* Spinal cord compression or symptomatic leptomeningeal metastasis\n* Toxicity from previous anti-tumor therapy not recovered to ≤CTCAE Grade 1 (except alopecia or platinum-induced peripheral neuropathy)\n* Symptomatic or unstable pleural\u002Fperitoneal effusion (stable ≥14 days after drainage is allowed)\n* History of other malignancies (except cured malignancies with no recurrence in 5 years: cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma)\n* History of interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or suspected ILD\n* Uncontrolled severe systemic diseases (e.g., hypertension, diabetes, NYHA III-IV heart failure, unstable angina, myocardial infarction within 1 year, active bleeding)\n* QTc \\>470 msec on resting ECG\n* Clinically significant QT prolongation or arrhythmias increasing QT risk (e.g., complete left bundle branch block, III° AV block, congenital long QT syndrome, severe hypokalemia, use of drugs causing QT prolongation)\n* Severe gastrointestinal dysfunction that impairs drug intake or absorption Infections requiring intravenous medication\n* Active mental illness or drug addiction\n* Known or suspected allergy to furmonertinib or its components\n* Pregnant or lactating women; women or their partners planning pregnancy during the study\n* Poor compliance (unable to follow study procedures)\n* Other conditions deemed unsuitable for enrollment by the investigator","ALL","18 Years","75 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This multicenter study evaluates the efficacy and safety of furmonertinib 160mg versus furmonertinib 80mg plus chemotherapy (carboplatin + pemetrexed) as first-line treatment for EGFR-mutated NSCLC patients with brain metastases. It aims to determine which approach is more effective and safer.",[77,78,24,79],"Non-small Cell Lung Cancer (NSCLC)","Brain Metastases","EGFR Mutation","NOT_YET_RECRUITING","2026-01-23",{"date":83,"type":84},"2026-01-26","ACTUAL",{"date":86,"type":71},"2026-01",{"date":88,"type":71},"2028-12",{"name":5,"class":6},1]