[{"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":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":11,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"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","phase-2-firmonertinib-160-mg-in-patients-with-egfr-mutant-advanced-nsclc-demonstrating-sd-after-8-week-induction-with-firmonertinib-80-mg-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":38,"type":39},28,"ESTIMATED","INTERVENTIONAL",[42],"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.",[45,46,47],"NSCLC Stage IV","EGFR Positive Non-small Cell Lung Cancer","EGFR-TKI Sensitizing Mutation","NOT_YET_RECRUITING","2026-01-18",{"date":51,"type":52},"2026-01-21","ACTUAL",{"date":54,"type":39},"2026-01-01",{"date":56,"type":39},"2032-12-31",{"name":5,"class":6}]