[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624770":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":23,"locations":28,"responsibleParty":41,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Limertinib Plus Radiotherapy","EXPERIMENTAL",null,[13],"Drug: Limertinib Plus Radiotherapy",[15],{"type":16,"name":9,"description":9,"armGroupLabels":17,"otherNames":11},"DRUG",[9],[19],{"name":20,"affiliation":21,"role":22},"Jiexia Zhang, Prof.","The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong","PRINCIPAL_INVESTIGATOR",[24],{"name":20,"role":25,"phone":26,"phoneExt":11,"email":27},"CONTACT","+8613903056432","drzjxcn@126.com",[29],{"facility":21,"status":11,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Guangzhou","China","CN",{"type":34,"coordinates":35},"Point",[36,37],113.25,23.11667,{"lat":37,"lon":36},[40],{"name":20,"role":25,"phone":26,"phoneExt":11,"email":27},{"type":22,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Jiexia Zhang","Professor","100624770","phase-2-limertinib-plus-radiotherapy-for-egfr-mutant-nsclc-with-brain-metastases-100624770",false,"NCT07413952","Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases","Efficacy and Safety of Limertinib (ASK120067) Combined With Radiotherapy as First-Line Treatment in Patients With EGFR-Mutant Non-Small Cell Lung Cancer and Brain Metastases: A Single-Arm, Multicenter, Prospective Phase II Study","Inclusion Criteria:\n\nPatients must voluntarily agree to participate in this study and sign a written informed consent form.\n\nPatients aged 18-75 years. Patients must have histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC), staged as IV according to the 9th edition of the American Joint Committee on Cancer (AJCC) TNM staging system.\n\nHistological or cytological reports issued by nationally accredited hospitals or third-party testing institutions confirming the presence of EGFR classical mutations (19Del \\& 21L858R).\n\nECOG PS score of 0-1, and an estimated survival of ≥3 months, as determined by the investigator.\n\nBrain metastases (meningeal\u002Fparenchymal) confirmed by CT or MRI, with or without symptoms.\n\nPatients must have at least one measurable lesion according to RECIST 1.1 criteria.\n\n≥3 primary brain lesions, with at least one lesion ≥2 cm. Patients must not have received any prior systemic anti-cancer treatment for advanced\u002Fmetastatic non-small cell lung cancer, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or investigational drug therapy. Patients who have received adjuvant or neoadjuvant therapy (chemotherapy and\u002For radiotherapy) are eligible if no disease progression occurred within 6 months after completion of treatment. Patients who have received local treatment (radiotherapy or pleural perfusion therapy) are also eligible if the treated lesions are not target lesions.\n\nPatients must meet the following organ function criteria:\n\nAbsolute neutrophil count (ANC) ≥1.5×10⁹\u002FL. 2) Platelet count ≥100×10⁹\u002FL. 3) Hemoglobin (HGB) ≥90 g\u002FL. 4) Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN). For patients with liver metastases, TBIL may be up to 3× ULN.\n\n5\\) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN. For patients with liver metastases, AST and ALT may be up to 5× ULN.\n\n6\\) Serum creatinine (SCr) ≤1.5× ULN, or creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n\nMale patients with reproductive potential and female patients who may become pregnant must use highly effective contraceptive methods during the study and for 12 months after treatment discontinuation.\n\nExclusion Criteria:\n\nPatients unable to confirm a diagnosis of non-small cell lung cancer (NSCLC) through histological or cytological examination.\n\nPatients expected to require other systemic anti-cancer treatments outside of this study during the trial period.\n\nPatients diagnosed with malignant tumors within the past 2 years, except for well-controlled cutaneous basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.\n\nPatients with significant gastrointestinal diseases that may affect drug intake or absorption, including but not limited to peptic ulcer disease or inflammatory bowel disease.\n\nPatients with known or suspected hypersensitivity to the study interventions (lielitinib and radiotherapy) or components of study-related preparations.\n\nPatients who have previously received any epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy.\n\nPatients who have used strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose of study drug, or who are expected to require long-term use of these medications during the trial. Additionally, patients who have used traditional Chinese medicine or preparations with anti-tumor indications within 2 weeks prior to the first dose of study drug, or who are expected to require such use during the trial, will also be excluded.\n\nPatients with a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring corticosteroid treatment. Patients with acute exacerbation or progressive pulmonary symptoms at baseline, or those considered unsuitable for inclusion by the investigator due to high-risk factors for interstitial lung disease, will also be excluded.\n\nPatients with significant arrhythmia (e.g., QT interval \\>470 ms) or heart failure (left ventricular ejection fraction \\\u003C50%).\n\nPregnant or lactating women. Patients currently participating in or who have participated in other clinical trials within the past 4 weeks.\n\nPatients with serious acute or chronic medical or psychiatric conditions, as determined by the investigator, that may increase the risks associated with study participation or interfere with the interpretation of study results.","ALL","18 Years","75 Years",{"count":55,"type":56},45,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","Patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with brain metastases remain a major clinical challenge. Although EGFR-TKIs have demonstrated intracranial activity, disease control is still suboptimal in some patients.\n\nLimertinib (ASK120067) is a novel third-generation EGFR tyrosine kinase inhibitor with favorable central nervous system penetration and encouraging intracranial antitumor activity. The potential synergistic effect of limertinib combined with radiotherapy warrants further investigation.\n\nThis prospective, multicenter, single-arm phase II study aims to evaluate the efficacy and safety of first-line limertinib combined with radiotherapy in this patient population.",[62],"NSCLC","NOT_YET_RECRUITING","2026-02-10",{"date":66,"type":67},"2026-02-17","ACTUAL",{"date":69,"type":56},"2026-04-01",{"date":71,"type":56},"2029-12-31",{"name":5,"class":6},1]