[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589560":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":47,"responsibleParty":81,"collaborators":28,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":28,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":28,"enrollmentInfo":92,"targetDuration":28,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":50,"whyStopped":28,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Allist Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Firmonertinib","EXPERIMENTAL","Oral administration, 240mg, QD。",[13],"Drug: Firmonertinib Mesilate Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"chemotherapy","ACTIVE_COMPARATOR","Pemetrexed Disodium for Injection： 500mg\u002Fm2, intravenous infusion. Cisplatin for injection：75 mg\u002Fm2， intravenous infusion. Carboplatin Injection：administered according to the AUC of 5 mg\u002Fml, intravenous infusion.",[19,20,21],"Drug: Pemetrexed Disodium for Injection","Drug: Cisplatin for injection","Drug: Carboplatin Injection",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Firmonertinib Mesilate Tablets","Usage and dosage: oral, 240mg, QD。 Medication duration: 21 days as a cycle, until intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Pemetrexed Disodium for Injection","Usage and dosage: 500mg\u002Fm2, intravenous infusion. Medication duration: 21 days as a cycle, D1 administration, until the occurrence of intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).",[15],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Cisplatin for injection","Usage and dosage: 75 mg\u002Fm2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.",[15],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Carboplatin Injection","Usage and dosage: give the drug according to AUC 5 mg\u002Fml, intravenous drip.\n\nMedication duration: 21 days as a cycle, D1 administration, up to 4 cycles.",[15],[42],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd","CONTACT","021-80423288","zhenhua.gong@allist.com.cn",[48,67],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63],{"name":64,"role":44,"phone":65,"phoneExt":28,"email":66},"Wu DaWei DaWei Wu，EC secretary","8610-87788495","cancergcp@163.com",{"facility":68,"status":50,"city":69,"state":70,"zip":28,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Shandong Tumor Hospital","Shandong","Jinan",{"type":57,"coordinates":72},[73,74],120.48412,40.28464,{"lat":74,"lon":73},[77],{"name":78,"role":44,"phone":79,"phoneExt":28,"email":80},"Shandong Tumor Hospital Shandong Tumor Hospital","0531-67626929","sdzlllh803@126.com",{"type":82,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100589560","phase-3-firmonertinib-versus-platinum-based-chemotherapy-as-first-line-treatment-for-nsclc-with-egfr-pacc-or-egfr-l861q-mutation-100589560",false,"NCT06956001","Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation","A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF).\n2. Age ≥18 years at the time of ICF signing.\n3. At least one measurable lesion per RECIST v1.1, meeting the following:\n\n   * No prior local therapy (e.g., radiotherapy)\n   * Not used for biopsy during screening\n4. Histologically\u002Fcytologically confirmed non-squamous NSCLC, classified as:\n\n   * Locally advanced (Stage IIIB\u002FIIIC, unsuitable for curative surgery and\u002For definitive chemoradiotherapy)\n   * Metastatic (Stage IV) (Based on UICC\u002FAJCC 8th edition TNM staging)\n5. Agreement to provide:\n\n   * Recent tumor tissue (from untreated lesions)\n   * Blood samples\n   * Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)\n6. No prior systemic therapy for advanced\u002Fmetastatic NSCLC.\n\n   * Allowed if: Prior (neo)adjuvant\u002Fdefinitive chemoradiotherapy completed ≥12 months before recurrence\u002Fprogression\n7. ECOG performance status 0-1.\n8. Life expectancy ≥12 weeks.\n9. Adequate bone marrow\u002Forgan function within 14 days before treatment (no transfusion\u002FG-CSF within 2 weeks prior).\n10. Women of childbearing potential (WOCBP):\n\n    * Abstinence or contraception use\n    * No egg donation\n11. Non-sterilized males:\n\n    * Abstinence or contraception use\n    * No sperm donation\n12. CNS metastases allowed if protocol-specified criteria are met.\n\nExclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed tumor with \\>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.\n2. Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.\n3. Prior treatments including:\n\n   1. Systemic anti-tumor therapy for advanced\u002Fmetastatic NSCLC (e.g., chemotherapy\u002Ftargeted\u002Fimmunotherapy). Neoadjuvant\u002Fadjuvant therapy exceptions per Inclusion Criterion #6.\n   2. \\>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).\n   3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).\n   4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.\n   5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose.\n   6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.\n   7. Major trauma\u002Fsurgery within 4 weeks prior to treatment initiation.\n4. Clinically significant gastrointestinal abnormalities, including:\n\n   * Moderate\u002Fsevere atrophic gastritis\n   * GI obstruction\u002Fperforation\n   * Chronic diarrhea\u002Fshort bowel syndrome\n   * Major upper GI surgery (e.g., gastrectomy)\n   * Inflammatory bowel disease (Crohn's\u002Fulcerative colitis) or active intestinal inflammation\n   * Inability to swallow tablets\n5. Uncontrolled systemic diseases.\n6. Severe acute\u002Fchronic infections.\n7. Interstitial lung disease (ILD)\u002Fnon-infectious pneumonia:\n\n   * History requiring clinical intervention\n   * Current presence\n   * Suspicious imaging findings unresolved at screening\n8. Clinically significant cardiovascular dysfunction (active or history).\n9. Tumor invasion of critical adjacent structures (heart\u002Fesophagus\u002FSVC etc.) with high bleeding\u002Ffistula risk. Exceptions may be considered if investigator assesses minimal risk.\n10. Pulmonary comorbidities causing severe impairment, including:\n\n    1. Baseline lung diseases (e.g., pulmonary embolism \\[≤3 months\\], severe asthma\u002FCOPD\u002Frestrictive disease)\n    2. Autoimmune\u002Fconnective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis)\n11. Residual toxicity \\>Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia\u002Fneuropathy).\n12. Concurrent malignancies except:\n\n    * Cured localized skin cancers (BCC\u002FSCC), superficial bladder cancer, cervical\u002Fbreast DCIS, or papillary thyroid cancer\n    * Other malignancies cured by radical therapy ≥3 years prior\n13. Pregnancy\u002Flactation or planned pregnancy within 6 months post-treatment.\n14. Inability to comply with study procedures\u002Ffollow-up.\n15. Known hypersensitivity to furmonertinib or excipients.\n16. History of allergic reactions to pemetrexed\u002Fcisplatin\u002Fcarboplatin.\n17. Other exclusionary per investigator judgment, including:\n\n    * Alcohol\u002Fdrug abuse\n    * Severe comorbidities (including psychiatric) requiring treatment\n    * Critical laboratory abnormalities\n    * Social\u002Ffamilial factors compromising safety\u002Fdata collection","ALL","18 Years",{"count":93,"type":94},300,"ESTIMATED","INTERVENTIONAL",[97],"PHASE3","This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.\n\nEligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.",[100,101],"EGFR","NSCLC (Advanced Non-small Cell Lung Cancer)",[103],"firmonertinib","2026-02-10",{"date":106,"type":107},"2026-02-12","ACTUAL",{"date":109,"type":107},"2024-11-19",{"date":111,"type":94},"2028-07",{"name":5,"class":6},2]