[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573407":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":51,"centralContacts":56,"locations":62,"responsibleParty":156,"collaborators":158,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":33,"eligibilityCriteria":173,"healthyVolunteers":169,"sex":174,"minAge":175,"maxAge":33,"enrollmentInfo":176,"targetDuration":33,"studyType":179,"phases":180,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":64,"whyStopped":33,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",[8,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Non-interventional prospective cohort and participants will receive standard of care pembrolizumab with or without chemotherapy.",[13,14,15,16,17,18],"Drug: Cisplatin","Drug: Carboplatin","Drug: Pemetrexed","Drug: Pembrolizumab","Drug: Abraxane","Drug: Paclitaxel",{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 2: arm A","Cohort 2 Arm A will enroll patients with NSCLC with PD-L1 TPS status ≥1% and ctDNA tumor fraction low\u002Fnegative and be treated with pembrolizumab monotherapy.",[16],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 2: arm B","Cohort 2 Arm B will enroll patients with NSCLC with any PD-L1 status and ctDNAtumor fraction intermediate\u002Fhigh -OR- PD-L1 TPS\\\u003C1% and any ctDNA level treated with chemotherapy plus pembrolizumab.",[13,14,15,16,17,18],[28,34,37,40,44,48],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Cisplatin","Given on day 1 of every 21-day cycle.",[9,24],null,{"type":29,"name":35,"description":31,"armGroupLabels":36,"otherNames":33},"Carboplatin",[9,24],{"type":29,"name":38,"description":31,"armGroupLabels":39,"otherNames":33},"Pemetrexed",[9,24],{"type":29,"name":41,"description":42,"armGroupLabels":43,"otherNames":33},"Pembrolizumab","Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.",[9,20,24],{"type":29,"name":45,"description":46,"armGroupLabels":47,"otherNames":33},"Abraxane","Given on days 1, 8, and 15 of each 21-day cycle.",[9,24],{"type":29,"name":49,"description":31,"armGroupLabels":50,"otherNames":33},"Paclitaxel",[9,24],[52],{"name":53,"affiliation":54,"role":55},"Jhanelle Gray, MD","Moffitt Cancer Center","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":33,"email":61},"Anahid Aminpour","CONTACT","813-745-0287","anahid.aminpour@moffitt.org",[63,105,118,130,143],{"facility":54,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-82.45843,27.94752,{"lat":74,"lon":73},[77,78,81,83,85,87,89,91,93,95,97,99,101,103],{"name":53,"role":55,"phone":33,"phoneExt":33,"email":33},{"name":79,"role":80,"phone":33,"phoneExt":33,"email":33},"Tiffany Apana, MSN, FNP-BC","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":33,"phoneExt":33,"email":33},"Alberto Chiappori, MD",{"name":84,"role":80,"phone":33,"phoneExt":33,"email":33},"Benjamin Creelan, MD",{"name":86,"role":80,"phone":33,"phoneExt":33,"email":33},"Eric Haura, MD",{"name":88,"role":80,"phone":33,"phoneExt":33,"email":33},"Bruna Pellini, MD",{"name":90,"role":80,"phone":33,"phoneExt":33,"email":33},"Andreas Saltos, MD",{"name":92,"role":80,"phone":33,"phoneExt":33,"email":33},"Michael Shafique, MD",{"name":94,"role":80,"phone":33,"phoneExt":33,"email":33},"Stephanee Smikker, MSPAS, PA-C",{"name":96,"role":80,"phone":33,"phoneExt":33,"email":33},"Tawee Tanvetyanon, MD",{"name":98,"role":80,"phone":33,"phoneExt":33,"email":33},"Sam Vafadar, PA-C, DHSc",{"name":100,"role":80,"phone":33,"phoneExt":33,"email":33},"Charles Lu, MD",{"name":102,"role":80,"phone":33,"phoneExt":33,"email":33},"Sonam Puri, MD",{"name":104,"role":80,"phone":33,"phoneExt":33,"email":33},"Samantha Klebowski, APRN-C",{"facility":106,"status":64,"city":107,"state":108,"zip":109,"country":68,"countryCode":69,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Johns Hopkins Sidney Kimmel Comprehensive Cancer Center","Baltimore","Maryland","21287",{"type":71,"coordinates":111},[112,113],-76.61219,39.29038,{"lat":113,"lon":112},[116],{"name":117,"role":55,"phone":33,"phoneExt":33,"email":33},"Julie Brahmer, MD",{"facility":119,"status":64,"city":120,"state":108,"zip":121,"country":68,"countryCode":69,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"TidalHealth Peninsula Regional","Salisbury","20801",{"type":71,"coordinates":123},[124,125],-75.59937,38.36067,{"lat":125,"lon":124},[128],{"name":129,"role":55,"phone":33,"phoneExt":33,"email":33},"Milcah Larks, MD",{"facility":131,"status":64,"city":132,"state":133,"zip":134,"country":68,"countryCode":69,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Montefiore Medical Cancer Center","The Bronx","New York","10461",{"type":71,"coordinates":136},[137,138],-73.86641,40.84985,{"lat":138,"lon":137},[141],{"name":142,"role":55,"phone":33,"phoneExt":33,"email":33},"Balazs Halmos, MD",{"facility":144,"status":64,"city":145,"state":146,"zip":147,"country":68,"countryCode":69,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Baptist Clinical Research Institute","Memphis","Tennessee","38120",{"type":71,"coordinates":149},[150,151],-90.04898,35.14953,{"lat":151,"lon":150},[154],{"name":155,"role":55,"phone":33,"phoneExt":33,"email":33},"Osarenren Ogbeide, MD",{"type":157,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[159,162,164],{"name":160,"class":161},"Merck Sharp & Dohme LLC","INDUSTRY",{"name":163,"class":161},"Foundation Medicine",{"name":165,"class":166},"Go-2 Lung","UNKNOWN","100573407","phase-2-prospective-trial-assessing-real-world-outcomes-response-to-pembro-in-black-patients-w-nsclc-100573407",false,"NCT06745882","Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w\u002F NSCLC","Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent\u002Fassent.\n* Must be ≥ 18 years of age on day of signing informed consent.\n* Be Black \u002F African American per self-report.\n* Have an ECOG performance status of 0- 2.\n* Have histologically or cytologically confirmed, advanced\u002Fmetastatic NSCLC.\n* Be treatment naïve in the advanced\u002Fmetastatic\u002Frecurrent disease setting.\n* No known EGFR\u002FALK\u002FROS1 tumor mutations. Liquid biopsies are acceptable.\n* Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and\u002For neoadjuvant and\u002For adjuvant immunotherapy and\u002For consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible.\n* Be planned\u002Feligible to receive first-line therapy in the advanced\u002Fmetastatic setting.\n* Have testing status for PDL1 tissue status.\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.\n* Adequate organ function.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n* Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy.\n\nCohorts 1, 2a and b: Exclusion Criteria:\n\n* Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard\u002Ftreating provider.\n* History of allogenic tissue\u002Fsolid organ transplant.\n\nCohort 2a and b Only: Exclusion Criteria:\n\n* Received prior treatment chemotherapy and\u002For immune checkpoint inhibitor therapy in the advanced\u002Fmetastatic setting for lung cancer.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses\n\n  ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy at C1D1. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted (i.e., ≤ 10 mg\u002Fday prednisone equivalents). A brief course (≤ 7 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n* Has active autoimmune disease that has required active systemic treatment in the past 2 years \\[i.e., with use of disease modifying agents, corticosteroids in doses greater than 10 mg of prednisone daily (or equivalent) or immunosuppressive drugs\\]. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, that would substantially increase the risk of incurring adverse events (AEs) from the study medications, that would interfere with the subject's participation for the full duration of the study or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has received a live vaccine within 30 days of planned start of study therapy.\n\nCohorts 1, 2a and b: Exclusion Criteria:\n\n* Has received an investigational agent or has used an investigational device within 3 weeks prior to study intervention administration.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has known untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have completed radiation therapy (where applicable), are clinically stable and have not required steroid treatment at ≥ 10 mg of prednisone for at least 3 days prior to the first dose of study intervention.\n* Severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients or has a known sensitivity as applicable to carboplatin, cisplatin, taxane or pemetrexed.","ALL","18 Years",{"count":177,"type":178},318,"ESTIMATED","INTERVENTIONAL",[181],"PHASE2","This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced\u002Fmetastatic NSCLC without known EGFR\u002FALK\u002FROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.",[184],"Non-small Cell Lung Cancer",[186],"Justice","2026-04-01",{"date":189,"type":190},"2026-04-02","ACTUAL",{"date":192,"type":190},"2025-06-13",{"date":194,"type":178},"2030-01",{"name":5,"class":6},5]