[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658117":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":11,"studyPopulation":11,"armGroups":31,"interventions":42,"overallOfficials":61,"centralContacts":65,"locations":11,"responsibleParty":71,"collaborators":11,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":11,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":11},{"fullName":5,"class":6},"Exelixis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator",null,"6 months",[14,17,19,21,23],{"measure":15,"description":11,"timeFrame":16},"Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator","Up to 30 months",{"measure":18,"description":11,"timeFrame":16},"Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator",{"measure":20,"description":11,"timeFrame":16},"PFS per RECIST v1.1 as assessed by Investigator",{"measure":22,"description":11,"timeFrame":16},"Overall Survival (OS)",{"measure":24,"description":11,"timeFrame":16},"Number of Participants With Adverse Events (AEs)",{"allocation":26,"interventionModel":27,"interventionModelDescription":11,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":11,"whoMasked":11},"NONE",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"Zanzalintinib + Pembrolizumab","EXPERIMENTAL","Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.\n\nParticipants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.",[37,38,39,40,41],"Drug: Carboplatin","Drug: Paclitaxel","Drug: Nab-paclitaxel","Drug: Pembrolizumab","Drug: Zanzalintinib",[43,48,51,54,58],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"DRUG","Carboplatin","Administered as part of SOC therapy as specified in the treatment arm.",[33],{"type":44,"name":49,"description":46,"armGroupLabels":50,"otherNames":11},"Paclitaxel",[33],{"type":44,"name":52,"description":46,"armGroupLabels":53,"otherNames":11},"Nab-paclitaxel",[33],{"type":44,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"Pembrolizumab","Administered as specified in the treatment arm.",[33],{"type":44,"name":59,"description":56,"armGroupLabels":60,"otherNames":11},"Zanzalintinib",[33],[62],{"name":63,"affiliation":5,"role":64},"Medical Director","STUDY_DIRECTOR",[66],{"name":67,"role":68,"phone":69,"phoneExt":11,"email":70},"Exelixis Clinical Trials","CONTACT","1-888-393-5494","druginfo@exelixis.com",{"type":72,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658117","phase-2-zanzalintinib-and-pembrolizumab-in-first-line-maintenance-for-metastatic-squamous-non-small-cell-lung-cancer-nsclc-100658117",false,"NCT07845786","Zanzalintinib and Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)","A Phase 2, Single-Arm, Multicenter Trial of Zanzalintinib in Combination With Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer","STELLAR-202","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of ≥ 6 months.\n* Stage IV squamous NSCLC as defined by American Joint Committee on Cancer (AJCC) 9th Edition.\n* Measurable disease according to RECIST v1.1 as determined by the investigator and documented prior to starting induction therapy.\n* Programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) \\\u003C 50% as assessed per local testing. To minimize assay variability, local laboratory must ascertain PD-L1 status using the PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx assay.\n\nKey Exclusion Criteria:\n\n* Nonsquamous histology NSCLC.\n* Tumor invasion, encasement of organs, or major blood vessels, if poses a significant increased risk of bleeding.\n* Targetable genomic aberrations for which approved targeted therapy is available.\n* The participant has uncontrolled, significant intercurrent or recent illness.\n* Active autoimmune disease or a history of autoimmune disease within 2 years prior to the first dose of induction therapy requiring systemic immunosuppressive therapy.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","The primary purpose of the study is to evaluate the effectiveness of zanzalintinib in combination with pembrolizumab as first-line maintenance therapy in participants with metastatic squamous NSCLC.",[91],"Squamous Non-Small Cell Lung Cancer (NSCLC)","NOT_YET_RECRUITING","2026-09-22",{"date":95,"type":96},"2026-09-29","ACTUAL",{"date":98,"type":85},"2026-12-15",{"date":100,"type":85},"2030-06-15",{"name":5,"class":6}]