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MEK inhibitors are recognized to play a significant role in the pathogenesis of plexiform neurofibromas associated with neurofibromatosis type 1.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"TQ-B3234 placebo without drug substance.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Qingfeng Li, Doctor","CONTACT","021 53315108","dr.liqingfeng@shsmu.edu.cn",[36,55,70,80,91,102,118,133,148,163,174,189,204,219,234,248,263,278,293,308,323,338,347,359,374,389,400,415,430],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Anhui Medical University","NOT_YET_RECRUITING","Hefei","Anhui","230000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.28083,31.86389,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":25,"email":54},"Beicheng Sun, 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Doctor","13857121888","sufanwu@163.com",{"type":446,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624297","phase-3-evaluation-of-tq-b3234-capsules-in-patients-with-symptomatic-non-surgical-type-1-neurofibromatosis-associated-plexiform-neurofibromas-100624297",false,"NCT07407803","Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas","Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQ-B3234 Capsules Versus Placebo in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas","Inclusion Criteria:\n\n* The subject voluntarily joins this study, signs the informed consent form, and demonstrates good compliance.\n* Age ≥18 years (calculated from the date of signing the informed consent form).\n* Diagnosis of symptomatic, non-resectable neurofibromatosis type 1 (NF1)-associated plexiform neurofibroma (PN) requiring systemic therapy per investigator judgment.\n* At least one measurable lesion with a dimension ≥3 cm.\n* There should be no significant changes in the use of chronic neuropathic pain medications within 28 days prior to study enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Laboratory tests meet the protocol criteria.\n* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion. A negative serum pregnancy test must be documented within 7 days prior to study enrollment. Men must agree to use effective contraception during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n* Confirmed or suspected malignant glioma or malignant peripheral nerve sheath tumor (MPNST) (excluding low-grade glioma, optic nerve glioma not requiring systemic therapy or radiotherapy); histological confirmation may be required.\n* History of or concurrent other malignancies within 5 years prior to first dosing.\n* Multiple factors affecting oral drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction, major bowel resection).\n* Adverse reactions from prior anti-tumor therapy not recovered to NCI CTCAE v6.0 grade ≤1, except grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy.\n* Major surgery, significant traumatic injury, or planned major surgery during the study within 4 weeks prior to first dosing; or presence of long-term non-healed wounds or fractures.\n* History of arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack (TIA), deep vein thrombosis, pulmonary embolism) or other severe thromboembolic events within 6 months prior to first dosing.\n* Active viral hepatitis with poor control.\n* Active syphilis requiring treatment.\n* Active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia.\n* History of substance abuse that cannot be controlled or presence of psychiatric disorders.\n* Planned or prior allogeneic bone marrow or solid organ transplantation.\n* History of hepatic encephalopathy.\n* History of or current retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), central serous retinopathy (CSR), glaucoma, or other significant ocular abnormalities (e.g., intraocular pressure \\>21mmHg).\n* Inability to undergo MRI and\u002For presence of MRI contraindications.\n* Major cardiovascular disease.\n* Active or uncontrolled severe infection.\n* Renal failure requiring hemodialysis or peritoneal dialysis.\n* History of immunodeficiency, including HIV-positive or other acquired\u002Fcongenital immunodeficiency diseases.\n* History of epilepsy.\n* Tumor-related symptoms and treatment.\n* Known hypersensitivity to study drug excipients.\n* Participation in and use of other PN clinical trial drugs within 4 weeks prior to first dosing.\n* Pregnant or lactating participants.\n* Any other condition that, in the investigator's judgment, poses a serious risk to participant safety or interferes with study completion.","ALL","18 Years",{"count":457,"type":458},177,"ESTIMATED","INTERVENTIONAL",[461],"PHASE3","This study aims to demonstrate that in subjects with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1, TQ-B3234 capsules significantly improve the objective response rate at Week 24 compared to placebo.",[464],"Plexiform Neurofibroma","2026-05-22",{"date":467,"type":468},"2026-05-27","ACTUAL",{"date":470,"type":468},"2026-03-31",{"date":472,"type":458},"2028-12",{"name":5,"class":6},29]