[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585930":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":30,"responsibleParty":45,"collaborators":30,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":30,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":30,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":30,"overallStatus":67,"whyStopped":30,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":30},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Glumetinib（200 mg） + Osimertinib","EXPERIMENTAL","Group 1: Glumetinib 200 mg oral QD + Osimertinib 80 mg oral QD.",[13,14],"Drug: Glumetinib Tablets","Drug: Osimertinib Mesylate Tablets",{"label":16,"type":10,"description":17,"interventionNames":18},"Glumetinib（300mg） + Osimertinib","Group 2: Glumetinib 300 mg oral QD + Osimertinib 80 mg oral QD;",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Osimertinib","Group 3: Osimertinib 80 mg oral QD.",[14,23],"Drug: Glumetinib Tablets Placebo",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Glumetinib Tablets","An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor",[9,16],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Osimertinib Mesylate Tablets","3rd EGFR-TKI",[9,16,20],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Glumetinib Tablets Placebo","Placebo",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Clinical Trials Information Group officer","CONTACT","031169085587","ctr-contact@cspc.cn",{"type":46,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100585930","phase-2-glumetinib-combined-with-osimertinib-treatment-for-non-small-cell-lung-cancer-patients-100585930",false,"NCT06908772","Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients","A Multicenter Phase II\u002FIII Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Male or female subjects aged 18 to 75 years (inclusive). 3. Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4. At least one measurable lesion, as defined by RECIST 1.1 criteria; 5. ECOG performance status of 0 or 1; 6. Expected survival ≥ 3 months; 7. Adequate function of major organs and bone marrow; 8. Women or man of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n1. Prior treatment with an EGFR inhibitor or MET inhibitor;\n2. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;\n3. Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong CYP3A4 inducers and inhibitors during the study;\n4. Patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant;\n5. Presence of active infection (e.g., subjects are receiving anti-infection therapy);\n6. Severe or uncontrolled cardiovascular disorder requiring treatment;\n7. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;\n8. Women who are pregnant or breastfeeding;","ALL","18 Years","75 Years",{"count":58,"type":59},390,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE2","PHASE3","To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.",[66],"Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression","NOT_YET_RECRUITING","2025-03-27",{"date":70,"type":71},"2025-04-03","ACTUAL",{"date":73,"type":59},"2025-04-01",{"date":75,"type":59},"2030-01-31",{"name":5,"class":6}]