[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545318":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":45,"locations":11,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":11},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"JMT101 combined with Osimertinib","EXPERIMENTAL",null,[13,14],"Drug: JMT101 Injection","Drug: Osimertinib tablet",{"label":16,"type":17,"description":18,"interventionNames":19},"Cisplatin combined with pemetrexed","ACTIVE_COMPARATOR","Participants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg\u002Fm\\^2 + cisplatin 75mg\u002Fm\\^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.",[20,21],"Drug: Cisplatin injection","Drug: Pemetrexed injection",[23,28,32,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","JMT101 Injection","JMT101 Injection, 6 mg\u002Fkg intravenously, over 90 mins every 14 days",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Osimertinib tablet","Osimertinib 160mg once po everyday",[9],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Cisplatin injection","Cisplatin 75mg\u002Fm\\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.",[16],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Pemetrexed injection","Pemetrexed 500mg\u002Fm\\^2, IV infusion, on day-1 at every cycle of 21 days.",[16],[41],{"name":42,"affiliation":43,"role":44},"Li Zhang, M.D.","Cancer Prevention and Treatment Center of Sun Yat sen University","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@mail.ecspc.com",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100545318","phase-3-jmt101-in-combination-with-osimertinib-versus-cisplatin-pemetrexed-in-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc-characterized-by-epithermal-growth-factor-receptor-egfr-exon-20ins-mutations-100545318",false,"NCT06380348","JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations","A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age between 18-75 years old.\n2. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue\u002Fblood sample.\n3. At least 1 measurable lesion per RECIST Version 1.1\n4. Life expectancy ≥ 12 weeks\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n6. Adequate organ and hematologic function\n\nExclusion Criteria:\n\n1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.\n2. Central nervous system metastasis with associated symptom and signs.\n3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.\n4. History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy\n5. As judged by the investigator, unsuitable for attending the study.","ALL","18 Years","75 Years",{"count":64,"type":65},398,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.\n\nPrimary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with\u002Fwithout) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).",[71],"Local Advanced or Metastatic NSCLC",[73,74],"Harboring EGFR 20ins mutation","Without prior systemic therapy","NOT_YET_RECRUITING","2024-04-18",{"date":78,"type":79},"2024-04-23","ACTUAL",{"date":81,"type":65},"2024-04-26",{"date":83,"type":65},"2028-03-26",{"name":5,"class":6}]