[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572295":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":63,"collaborators":20,"id":65,"slug":20,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":20,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced Dose Combination Therapy","EXPERIMENTAL","Squamous cell histology:\n\n1. Carboplatin AUC 3 every 21 days IV for 4 cycles\n2. Paclitaxel 135 mg\u002Fm2 every 21 IV days for 4 cycles\n3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles\n\nNon-squamous histology:\n\n1. Carboplatin AUC 3 every 21 days IV for 4 cycles\n2. Pemetrexed 375 mg\u002Fm2 every 21 IV days for 4 cycles\n3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles",[13],"Drug: Reduced Dose of Chemotherapy and Immunotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Reduced Dose of Chemotherapy and Immunotherapy","Eligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg\u002Fm2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg\u002Fm2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are collectively the maintenance portion of treatment) or until disease progression or unacceptable toxicity.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jonathan Berkman, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Massey IIT Research Operations","CONTACT","804-628-6430","masseyepd@vcu.edu",[32,50],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Richmond","Virginia","23298","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.46026,37.55376,{"lat":43,"lon":42},[46,49],{"name":47,"role":28,"phone":29,"phoneExt":20,"email":48},"Massey Lung Team","masseylung@vcu.edu",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":51,"status":33,"city":52,"state":35,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"VCU Health Tappahannock Hospital","Tappahannock","22560",{"type":40,"coordinates":55},[56,57],-76.85913,37.92541,{"lat":57,"lon":56},[60,62],{"name":61,"role":28,"phone":29,"phoneExt":20,"email":48},"Massey CTO Lung Team",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":64,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100572295",false,"NCT06731413","Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w\u002FAdv \u003C50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)","Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS \u003C50% Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)\n* Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation\n* No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.\n* Age 70 or meeting frailty definition or above at the date of signing informed consent\n* Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)\n* PD-L1 tumor proportion score (TPS) of less than 50%\n* Eastern Cooperative Oncology Group (ECOG) PS of 0-3\n* Have measurable disease based on RECIST 1.1 as determined by the local site investigator\u002Fradiology assessment\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL\n* Platelets ≥ 75,000\u002FμL\n* Hemoglobin (Hgb) ≥ 8.0 g\u002FdL (transfusion permitted)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) \u002Falanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with life expectancy of less than 3 months at the time of enrollment\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)\n* Diagnosis of interstitial lung disease\n* Creatinine clearance of \\\u003C30 mL\u002Fmin\n* Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible\n* Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:\n\n  * Doses less than or equal to the equivalent of prednisone 10 mg daily\n  * Short courses of steroids that are discontinued prior to enrollment\n  * Inhaled, intranasal and\u002For topical steroids\n  * Dexamethasone taper for treating vasogenic edema associated with CNS disease","ALL","18 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent\u002Fmetastatic PD-L1 TPS\\\u003C50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.",[81,82,83,84],"Non-Small Cell Lung Cancer","NSCLC","Advanced Non-Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[86],"Non-Small Cell Lung Cancer, NSCLC","2026-05-29",{"date":89,"type":90},"2026-06-02","ACTUAL",{"date":92,"type":90},"2025-02-11",{"date":94,"type":75},"2033-07-30",{"name":5,"class":6},2]