[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615864":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":27,"slug":11,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":11,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":11},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Firmonertinib 160mg","EXPERIMENTAL",null,[13],"Drug: Firmonertinib 160mg",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Patients enter an 8-week induction phase at 80 mg once daily. Those with stable disease per RECIST v1.1 at Week 8 escalate to 160 mg daily until disease progression or unacceptable toxicity.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Sen Han, MD","CONTACT","010-88121122","handsomehansen1@126.com",{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100615864",false,"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.","ALL","18 Years","75 Years",{"count":37,"type":38},28,"ESTIMATED","INTERVENTIONAL",[41],"PHASE2","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.",[44,45,46],"NSCLC Stage IV","EGFR Positive Non-small Cell Lung Cancer","EGFR-TKI Sensitizing Mutation","NOT_YET_RECRUITING","2026-01-18",{"date":50,"type":51},"2026-01-21","ACTUAL",{"date":53,"type":38},"2026-01-01",{"date":55,"type":38},"2032-12-31",{"name":5,"class":6}]