[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659923":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":32,"overallOfficials":18,"centralContacts":38,"locations":18,"responsibleParty":44,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":62,"conditions":63,"keywords":18,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":18},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological complete response (pCR) rate","The proportion of subjects undergoing lung cancer resection who have no residual viable tumor cells in both the postoperative tumor bed and lymph nodes.","up to 30 months",[14],{"measure":15,"description":16,"timeFrame":17},"Progression-free survival (PFS)","Time from enrollment to tumor progression or death from any cause, whichever occurs first.","up to 40 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Bevacizumab combined with iruplinalkib","EXPERIMENTAL","The neoadjuvant treatment phase consists of 4 cycles (Q3W) of bevacizumab (15 mg\u002Fkg, intravenous infusion on day 1 of each cycle) combined with iruplinalkib (oral, with a 7-day lead-in of 60 mg once daily, then escalated to 180 mg once daily if tolerated). Surgery is performed 4 weeks after completion of neoadjuvant therapy, and adjuvant maintenance therapy with iruplinalkib monotherapy (180 mg once daily, for up to 2 years) is initiated within 4-8 weeks post-surgery. Discontinuation criteria include disease progression, unacceptable toxicity, or loss of clinical benefit.",[31],"Drug: Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":18},"DRUG","Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:","Eligible patients receive 4 cycles (Q3W) of bevacizumab (15 mg\u002Fkg IV on D1) plus iruplinalkib (60 mg oral lead-in for 7 days, then 180 mg daily). Surgery is performed 4 weeks after neoadjuvant therapy, followed by adjuvant iruplinalkib monotherapy for up to 2 years (starting within 4-8 weeks post-surgery), continued until progression, unacceptable toxicity, or loss of benefit.",[27],[39],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Peng Zhang","CONTACT","13512185932","zhangpeng1121@tongji.edu.cn",{"type":45,"investigatorFullName":40,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","DR.","100659923","neoadjuvant-iruplinalkib-and-bevacizumab-in-alk-positive-nsclc-a-phase-ii-single-arm-trial-100659923",false,"NCT07870733","Neoadjuvant Iruplinalkib and Bevacizumab in ALK-positive NSCLC: A Phase II Single-arm Trial","A Single-arm, Phase II Clinical Study of Iruplinalkib Combined With Bevacizumab as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer.","Inclusion Criteria:\n\n* Signed informed consent.\n\nAge 18-80 years, both sexes.\n\nHistologically or cytologically confirmed NSCLC.\n\nStage II-III NSCLC per investigator, and ALK-positive.\n\nAt least one measurable lesion per RECIST 1.1.\n\nECOG performance status 0-1.\n\nAdequate organ and bone marrow function (within 7 days before first dose, no transfusion or growth factor support within 14 days):\n\nHb ≥90 g\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥90×10⁹\u002FL;\n\nCr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT\u002FAST ≤3.0×ULN (or ≤5.0×ULN if liver metastases), ALB ≥25 g\u002FL;\n\nINR ≤1.5×ULN, PT\u002FAPTT ≤1.5×ULN (or within therapeutic range for anticoagulated patients).\n\nFEV₁ \\>60% predicted.\n\nWomen of childbearing potential: negative pregnancy test (serum\u002Furine) within 7 days before enrollment and use of reliable contraception from screening to 3 months after last study drug. Men: adequate contraception or surgically sterile.\n\nExpected survival ≥12 weeks.\n\nExclusion Criteria:\n\n* Hypersensitivity to iruplinalkib, bevacizumab, or any excipients.\n\nPrior targeted therapy (TKI or mAb), immunotherapy, or investigational drugs for NSCLC.\n\nMixed small-cell and non-small-cell histology.\n\nOther malignancy within 5 years, except cured basal cell carcinoma, early GI cancer (endoscopically resected), cervical CIS, DCIS, papillary thyroid cancer, or other cured cancers deemed not to affect survival.\n\nUnstable systemic disease: active infection, uncontrolled hypertension (\\>160\u002F110 mmHg), unstable angina or angina within 3 months, CHF (NYHA ≥II), MI within 6 months, clinically significant arrhythmia requiring treatment, or QTc \\>480 ms (average of 3 consecutive measurements if prolonged).\n\nHistory of extensive diffuse interstitial lung disease or grade 3\u002F4 pulmonary fibrosis\u002FILD (excluding localized radiation pneumonitis).\n\nCongenital or acquired immunodeficiency (e.g., HIV).\n\nMajor surgery within 4 weeks before study treatment, or planned major surgery during study.\n\nInability to swallow tablets or malabsorption affecting GI absorption.\n\nKnown risk of GI perforation or intestinal obstruction.\n\nPregnant or lactating women.\n\nAny other condition (e.g., alcohol\u002Fdrug abuse, serious concomitant disease including psychiatric, severe laboratory abnormalities, or social factors) that, in the investigator's opinion, could interfere with study conduct or patient safety.\n\nHistory of abdominal fistula, GI perforation, intra-abdominal abscess, or thrombotic disease within 6 months, or judged intolerant to bevacizumab.\n\nEvidence of hereditary bleeding diathesis or coagulopathy.\n\nMinor surgery (e.g., catheter placement) within 48 hours before first bevacizumab infusion.\n\nImaging evidence of tumor invasion of major vessels (e.g., pulmonary artery or SVC) with bleeding risk per investigator.\n\nOther factors making the patient unsuitable for the study per investigator.","ALL","18 Years","80 Years",{"count":58,"type":59},40,"ESTIMATED","INTERVENTIONAL",[20],"This is a single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC. Eligible patients receive 4 cycles (Q3W) of iruplinalkib (60 mg lead-in for 7 days, then 180 mg daily, PO) plus bevacizumab (15 mg\u002Fkg, IV, D1). Surgery is performed 4 weeks later, followed by adjuvant iruplinalkib monotherapy for up to 2 years. Primary endpoint is major pathological response (MPR) rate; secondary endpoints include safety, R0 resection rate, and survival outcomes.",[64,65,66],"ALK","NSCLC","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-10-06",{"date":70,"type":71},"2026-10-13","ACTUAL",{"date":73,"type":59},"2026-09-15",{"date":75,"type":59},"2031-07-01",{"name":5,"class":6}]