[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-tki-sensitizing-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-tki-sensitizing-mutation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635340","phase-2-zorifertinib-plus-intra-ommaya-csf-chemotherapy-for-leptomeningeal-progression-in-nsclc-after-third-generation-egfr-tki-100635340",false,"NCT07551414","Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI","A Prospective Study of Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI Therapy","Inclusion Criteria:\n\n* 1\\. Have fully understood the study and voluntarily signed the Informed Consent Form (ICF).\n\n  2\\. Subjects must be 18-75 years old before signing the Informed Consent Form (ICF).\n\n  3\\. During the screening phase, subjects must be diagnosed with non-small cell lung cancer (NSCLC) and test positive for EGFR-sensitive mutations (L858R and\u002For Exon 19Del).\n\n  4\\. Subjects who developed leptomeningeal progression after treatment with third-generation EGFR-TKIs and have no extracranial progression. The original third-generation EGFR-TKIs may be continued at the original dose or reduced dose.\n\n  5\\. Subjects diagnosed with leptomeningeal metastasis must have positive cerebrospinal fluid (CSF) cytology results. Subjects with negative CSF cytology but clinically diagnosed leptomeningeal metastasis based on symptoms, brain or spinal MRI imaging are also eligible for enrollment.\n\n  6\\. Subjects with both leptomeningeal progression and brain parenchymal progression are allowed to enroll.\n\n  7\\. Have undergone Ommaya reservoir implantation, with confirmation of no surgery-related complications and normal function of the Ommaya reservoir.\n\n  8\\. If accompanied by neurological symptoms, the following conditions must be met: able to take oral medication and swallow drugs; no need to increase hormone dosage to control central nervous system symptoms for at least 1 week prior to study treatment (i.e., symptom stability).\n\n  9\\. All anti-tumor therapy-related toxicities must have recovered to ≤ Grade 1 per CTCAE 5.0 criteria prior to starting study treatment (neurotoxicity related to platinum-based therapy may recover to ≤ Grade 2 per CTCAE 5.0 criteria); alopecia of any grade is allowed for enrollment.\n\n  10\\. Screening period test results must meet the following criteria:\n* Neutrophil count ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 100 × 10⁹\u002FL\n* Hemoglobin ≥ 90 g\u002FL\n* Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated via Cockcroft-Gault formula) ≥ 50 mL\u002Fmin\n* Total serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN allowed for patients with Gilbert syndrome or liver metastasis)\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN allowed for patients with liver metastasis)\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN allowed for patients with liver metastasis) 11. Estimated survival duration ≥ 3 months. 12. Karnofsky Performance Status (KPS) score ≥ 60.\n\nExclusion Criteria:\n\n* 1\\. Subjects with a history of cranial or spinal radiotherapy within 6 months prior to study drug administration are ineligible for enrollment. Radiotherapy for bone metastases within 3 months prior to study drug administration is also not permitted.\n\n  2\\. Subjects who have undergone major surgical procedures (e.g., intrathoracic, intra-abdominal, or pelvic surgery) within 4 weeks prior to the first dose of study treatment, or who have not yet recovered from side effects related to such surgeries, are ineligible for enrollment.\n\n  3\\. Subjects with any other currently active malignant tumor besides NSCLC are excluded.\n\n  4\\. Subjects with clinically significant, uncontrolled cardiac disease and\u002For cardiac events occurring within the past 6 months, such as:\n  1. Myocardial infarction within 6 months prior to screening;\n  2. Documented history of heart failure (NYHA Class III-IV);\n  3. Uncontrolled hypertension: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg, regardless of antihypertensive medication use (adjustment of antihypertensive drugs prior to screening is permitted);\n  4. Drug-refractory arrhythmias;\n  5. Screening QTcF \\>470 ms;\n  6. Left ventricular ejection fraction (LVEF) \\\u003C50%. 5. Subjects with gastrointestinal diseases or severe impairment of gastrointestinal function that may significantly affect drug absorption (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).\n\n  6\\. Subjects unable to discontinue the following medications within 1 week prior to study drug administration and during the study period:\n  1. Strong inducers or strong inhibitors of CYP3A4;\n  2. Drugs that may prolong the QT interval or induce torsades de pointes. 7. Subjects with prior or current HIV infection are excluded. HCV antibody-positive subjects may be enrolled if HCV RNA is undetectable (with the lower limit of detection defined per each center's standards) and there is no concurrent hepatitis B virus (HBV) infection. HBV-infected subjects may be enrolled if they meet the following conditions:\n\n  \u003C!-- -->\n\n  1. For active hepatitis B patients: at least 6 weeks of antiviral therapy prior to starting study treatment, with HBV DNA \\\u003C100 IU\u002FmL and ALT\u002FAST levels \\\u003CULN;\n  2. For resolved or chronic hepatitis B patients: at least 2 weeks of prophylactic antiviral therapy prior to starting study treatment, with HBV DNA below 100 IU\u002FmL (e.g., inactive carriers) and ALT\u002FAST levels \\\u003CULN.\n\n  8\\. Pregnant or breastfeeding women; women of childbearing potential must agree to use highly effective contraception during the treatment period and for 3 months after the last dose; fertile men must also use highly effective contraception during the treatment period and for 6 months after the last dose.\n\n  9\\. Subjects with a prior history of interstitial lung disease, including clinically significant radiation pneumonitis (e.g., affecting daily life or requiring therapeutic intervention).\n\n  10\\. Subjects who have previously received zorifertinib or its active pharmaceutical ingredient.\n\n  11\\. Known hypersensitivity to zorifertinib's active ingredients, excipients, or drugs with similar chemical structures or classes.\n\n  12\\. Subjects with other comorbid diseases or factors that, in the investigator's judgment, would pose excessive risk to the subject upon participation in the clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A Prospective Study of Zorifertinib Combined with Intra-Ommaya Reservoir Cerebrospinal Fluid Chemotherapy for Leptomeningeal Progression in NSCLC Patients After Third-Generation EGFR-TKI Therapy",[27,28,29,30],"NSCLC (Non-small Cell Lung Carcinoma)","Leptomeningeal Metastasis","EGFR-TKI Sensitizing Mutation","Zorifertinib",[28,32,33,29],"NSCLC","zorifertinib","NOT_YET_RECRUITING","2026-04-22",{"date":37,"type":38},"2026-04-24","ACTUAL",{"date":40,"type":21},"2026-05-30",{"date":42,"type":21},"2028-05-30",{"name":44,"class":45},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100615864","phase-2-firmonertinib-160-mg-in-patients-with-egfr-mutant-advanced-nsclc-demonstrating-sd-after-8-week-induction-with-firmonertinib-80-mg-100615864","NCT07298148","Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg","A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg","Inclusion Criteria:\n\n* Age 18-75 years.\n* ECOG performance status 0-1; life expectancy ≥3 months.\n* Histologically\u002Fcytologically confirmed advanced\u002Fmetastatic non-squamous NSCLC unsuitable for curative therapy.\n* Documented EGFR 19del or L858R mutation.\n* No prior systemic therapy for advanced disease.\n* Stable disease after 8 weeks of Firmonertinib 80 mg daily.\n* more than 1 measurable lesion per RECIST v1.1.\n* Adequate hematologic, renal, hepatic, and coagulation function.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Hypersensitivity to Firmonertinib or related compounds.\n* Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53\u002FRB1).\n* Prior EGFR-TKI therapy or prohibited concomitant medications.\n* Unresolved toxicities \\>CTCAE Grade 1 (except allowed conditions).\n* Symptomatic CNS metastases or spinal cord compression.\n* GI disorders impairing drug absorption.\n* Uncontrolled systemic diseases or active infections (HBV\u002FHCV\u002FHIV).\n* Interstitial lung disease (history or active).\n* Clinically significant cardiac abnormalities including QTc \\>470 ms or LVEF \\\u003C50%.\n* Pregnancy or breastfeeding.\n* Any condition compromising compliance.\n* CR, PR, or PD at completion of induction therapy.",{"count":55,"type":21},28,[24],"This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.",[59,60,29],"NSCLC Stage IV","EGFR Positive Non-small Cell Lung Cancer","2026-01-18",{"date":63,"type":38},"2026-01-21",{"date":65,"type":21},"2026-01-01",{"date":67,"type":21},"2032-12-31",{"name":69,"class":45},"Peking University Cancer Hospital & Institute",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":46},"100208734","a-retrospective-study-of-egfr-tkisgefitinib-erlotinib-and-osimertinib-in-nsclc-patients-treatment-100208734","NCT01994057","A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment","Retrospective Study Based on Somatic Mutations, Genetic Polymorphisms and Metabolomics Related to Individual Variations of Drug Effect and Adverse Drug Reaction of EGFR-TKIs,Gefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment.","Inclusion Criteria:\n\nThe main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:\n\nuncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.","85 Years",{"count":79,"type":21},1000,"OBSERVATIONAL","For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.",[83,84,29,85,86],"Non-small Cell Lung Cancer (NSCLC)","EGFR-TKI Resistant Mutation","Germline Mutations","Somatic Mutation",[88,89,90,91,92],"Non-small cell lung cancer (NSCLC);","EGFR-TKI;","Pharmacogenetics;","Precision medicine","somatic mutations ,germline mutations;","RECRUITING","2023-04-10",{"date":96,"type":38},"2023-04-12",{"date":98,"type":4},"2012-09",{"date":100,"type":21},"2026-12",{"name":102,"class":45},"Sun Yat-sen University"]