[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641898":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":45,"studyPopulation":45,"armGroups":51,"interventions":66,"overallOfficials":45,"centralContacts":72,"locations":45,"responsibleParty":81,"collaborators":45,"id":83,"slug":45,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":45,"enrollmentInfo":92,"targetDuration":45,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":45,"overallStatus":101,"whyStopped":45,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":45},{"fullName":5,"class":6},"Verastem, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1","Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)","6 months",{"measure":14,"description":15,"timeFrame":12},"To characterize the safety and tolerability of VS-7375 monotherapy administered on a daily oral schedule in participants with KRAS G12D-mutated NSCLC","Proportion\u002Fnumber of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions\u002Freductions and discontinuations",[17,21,25,28,32,35],{"measure":18,"description":19,"timeFrame":20},"Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments","To evaluate additional efficacy parameters of VS-7375 monotherapy administered on a daily oral schedule in participants with KRAS G12D-mutated NSCLC","24 months",{"measure":22,"description":23,"timeFrame":24},"Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax","Maximum concentration (Cmax)","20 weeks",{"measure":26,"description":27,"timeFrame":24},"Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC","Area under plasma Concentration (AUC) 0 to t",{"measure":29,"description":30,"timeFrame":31},"To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type","CA19-9, CEA, CA-125","Up to 2.5 years",{"measure":33,"description":34,"timeFrame":20},"To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30)","The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of non-small cell lung cancer patients",{"measure":36,"description":37,"timeFrame":20},"Time to next therapy","To assess the interval between initiation of study treatment and initiation of subsequent treatment",[39],{"measure":40,"description":41,"timeFrame":20},"Imaging of tumor metabolism changes","To assess tumor metabolism dynamics on FDG-PET\u002FCT",{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":45,"timePerspective":45,"maskingInfo":47},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":48,"maskingDescription":45,"whoMasked":49},"SINGLE",[50],"OUTCOMES_ASSESSOR",[52,58,62],{"label":53,"type":54,"description":55,"interventionNames":56},"VS-7375 Monotherapy 2L\u002F3L","EXPERIMENTAL","2L\u002F3L VS-7375 dose",[57],"Drug: VS-7375",{"label":59,"type":54,"description":60,"interventionNames":61},"VS-7375 Monotherapy 2L\u002F3L Preferred Dose","2L\u002F3L Preferred VS-7375 dose",[57],{"label":63,"type":54,"description":64,"interventionNames":65},"2L-4L with brain metastasis","2L-4L VS-7375 dose",[57],[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":45},"DRUG","VS-7375","Taken by mouth",[63,53,59],[73,78],{"name":74,"role":75,"phone":76,"phoneExt":45,"email":77},"Verastem Call Center","CONTACT","7812924204","VS-7375-202TrialSupport@verastem.com",{"name":79,"role":75,"phone":45,"phoneExt":45,"email":80},"Ting Wu, MD","VS-7375-202Medical@verastem.com",{"type":82,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100641898",false,"NCT07659782","A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer","A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON\u002FOFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)","TARGET-D 202","Inclusion Criteria:\n\n* Histopathology confirmed unresectable locally advanced or metastatic NSCLC\n* Measurable disease per RECIST 1.1\n* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)\n* ECOG PS=0 or 1\n* Adequate organ function\n* Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.\n* Have documented disease progression during or following their most recent prior line of therapy.\n\nPatients with 2L\u002F3L on stable or preferred dose:\n\n* Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.\n\nPatients with 2L-4L with brain metastases:\n\n* Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.\n* Have asymptomatic and untreated brain metastases\n* At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm.\n\nExclusion Criteria:\n\n* Have any other documented co-existing common RAS mutation(s)\n* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter\n* Major surgery within 4 weeks of first treatment dose\n* Radiation therapy (RT) within 1 week of first treatment dose\n* History of drug-induced Interstitial Lung Disease\n* Receipt of prior direct RAS inhibitor\n* Untreated or symptomatic CNS metastasis\n* Receipt of strong CYP3A4 inhibitor\u002Finducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter\n* Receipt of PPI or H2 blocker within 5 days\n* Inability to swallow oral medication\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years",{"count":93,"type":94},105,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer",[100],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-06-15",{"date":104,"type":105},"2026-06-22","ACTUAL",{"date":107,"type":94},"2026-06",{"date":109,"type":94},"2028-12",{"name":5,"class":6}]