[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06745882":3,"trial-entities:NCT06745882":240,"trial-summary:NCT06745882":244},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":55,"secondary_outcomes":65,"sex":76,"minimum_age":77,"maximum_age":17,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":111,"locations":114,"central_contacts":230,"overall_officials":236,"references":238,"see_also_links":239},"NCT06745882","MCC-21630","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","RECRUITING","2030-01","2026-08","2026-08-26","2025-06-13","H. Lee Moffitt Cancer Center and Research Institute","OTHER",true,"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.",null,[19],"Non-small Cell Lung Cancer",[21],"Justice","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},318,"ESTIMATED",[30,37,40,43,48,52],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Cisplatin","Given on day 1 of every 21-day cycle.",[35,36],"Cohort 1","Cohort 2: arm B",{"type":31,"name":38,"description":33,"armGroupLabels":39},"Carboplatin",[35,36],{"type":31,"name":41,"description":33,"armGroupLabels":42},"Pemetrexed",[35,36],{"type":31,"name":44,"description":45,"armGroupLabels":46},"Pembrolizumab","Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.",[35,47,36],"Cohort 2: arm A",{"type":31,"name":49,"description":50,"armGroupLabels":51},"Abraxane","Given on days 1, 8, and 15 of each 21-day cycle.",[35,36],{"type":31,"name":53,"description":33,"armGroupLabels":54},"Paclitaxel",[35,36],[56,60,63],{"measure":57,"description":58,"timeFrame":59},"Cohort 1: Real World Overall Survival (rwOS)","Real-world overall survival (rwOS) is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.","Up to 36 Months",{"measure":61,"description":62,"timeFrame":59},"Cohort 2 Arm A: Progression Free Survival (PFS)","Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.",{"measure":64,"description":62,"timeFrame":59},"Cohort 2 Arm B: Progression Free Survival (PFS)",[66,70,73],{"measure":67,"description":68,"timeFrame":69},"Cohort 1: Baseline ctDNA","Baseline ctDNA will be summarized by mean, median, minimum, maximum, standard deviation, and coefficient of variation.","At Baseline",{"measure":71,"description":72,"timeFrame":59},"Cohort 2: Arm A and Arm B Objective Response Rate (ORR)","Objective response rate will be determined by summing the rates of complete response and partial response.",{"measure":74,"description":75,"timeFrame":59},"Cohort 2: Arm A and Arm B Overall Survival (OS)","Overall Survival is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.","ALL","18 Years",false,{"inclusion":80,"exclusion":96,"raw_text":110},[81,82,83,84,85,86,87,88,89,90,91,92,93,94,95],"Be willing and able to provide written informed consent\u002Fassent.","Must be ≥ 18 years of age on day of signing informed consent.","Be Black \u002F African American per self-report.","Have an ECOG performance status of 0- 2.","Have histologically or cytologically confirmed, advanced\u002Fmetastatic NSCLC.","Be treatment naïve in the advanced\u002Fmetastatic\u002Frecurrent disease setting.","No known EGFR\u002FALK\u002FROS1 tumor mutations. Liquid biopsies are acceptable.","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.","Be planned\u002Feligible to receive first-line therapy in the advanced\u002Fmetastatic setting.","Have testing status for PDL1 tissue status.","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.","Adequate organ function.","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.","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.","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.",[97,98,99,100,101,102,103,104,105,106,107,108,109],"Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard\u002Ftreating provider.","History of allogenic tissue\u002Fsolid organ transplant.","Received prior treatment chemotherapy and\u002For immune checkpoint inhibitor therapy in the advanced\u002Fmetastatic setting for lung cancer.","Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses","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.","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.","Has an active infection requiring systemic therapy.","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.","Has received a live vaccine within 30 days of planned start of study therapy.","Has received an investigational agent or has used an investigational device within 3 weeks prior to study intervention administration.","History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.","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.","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.","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.",[112,113],"ADULT","OLDER_ADULT",[115,155,166,177,187,198,209,220],{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":120,"contacts":121,"geoPoint":152},"Moffitt Cancer Center","Tampa","Florida","33612","United States",[122,125,128,130,132,134,136,138,140,142,144,146,148,150],{"name":123,"role":124},"Jhanelle Gray, MD","PRINCIPAL_INVESTIGATOR",{"name":126,"role":127},"Tiffany Apana, MSN, FNP-BC","SUB_INVESTIGATOR",{"name":129,"role":127},"Alberto Chiappori, MD",{"name":131,"role":127},"Benjamin Creelan, MD",{"name":133,"role":127},"Eric Haura, MD",{"name":135,"role":127},"Bruna Pellini, MD",{"name":137,"role":127},"Andreas Saltos, MD",{"name":139,"role":127},"Michael Shafique, MD",{"name":141,"role":127},"Stephanee Smikker, MSPAS, PA-C",{"name":143,"role":127},"Tawee Tanvetyanon, MD",{"name":145,"role":127},"Sam Vafadar, PA-C, DHSc",{"name":147,"role":127},"Charles Lu, MD",{"name":149,"role":127},"Sonam Puri, MD",{"name":151,"role":127},"Samantha Klebowski, APRN-C",{"lat":153,"lon":154},27.94752,-82.45843,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":120,"contacts":160,"geoPoint":163},"Our Lady of the Lake Physician's Group","Baton Rouge","Louisiana","70805",[161],{"name":162,"role":124},"Marshall Stagg, MD",{"lat":164,"lon":165},30.44332,-91.18747,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":120,"contacts":171,"geoPoint":174},"Johns Hopkins Sidney Kimmel Comprehensive Cancer Center","Baltimore","Maryland","21287",[172],{"name":173,"role":124},"Julie Brahmer, MD",{"lat":175,"lon":176},39.29038,-76.61219,{"facility":178,"status":8,"city":179,"state":169,"zip":180,"country":120,"contacts":181,"geoPoint":184},"TidalHealth Peninsula Regional","Salisbury","20801",[182],{"name":183,"role":124},"Milcah Larks, MD",{"lat":185,"lon":186},38.36067,-75.59937,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":120,"contacts":192,"geoPoint":195},"Montefiore Medical Cancer Center","The Bronx","New York","10461",[193],{"name":194,"role":124},"Balazs Halmos, MD",{"lat":196,"lon":197},40.84985,-73.86641,{"facility":199,"status":8,"city":200,"state":201,"zip":202,"country":120,"contacts":203,"geoPoint":206},"FirstHealth of the Carolinas, Inc.","Pinehurst","North Carolina","28374",[204],{"name":205,"role":124},"Charles Kuzma, MD",{"lat":207,"lon":208},35.19543,-79.46948,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":120,"contacts":214,"geoPoint":217},"Baptist Clinical Research Institute","Memphis","Tennessee","38120",[215],{"name":216,"role":124},"Osarenren Ogbeide, MD",{"lat":218,"lon":219},35.14953,-90.04898,{"facility":221,"status":8,"city":222,"state":212,"zip":223,"country":120,"contacts":224,"geoPoint":227},"Nashville General Hospital","Nashville","37208",[225],{"name":226,"role":124},"Robin Jacob, MD",{"lat":228,"lon":229},36.16589,-86.78444,[231],{"name":232,"role":233,"phone":234,"email":235},"Anahid Aminpour","CONTACT","813-745-0287","anahid.aminpour@moffitt.org",[237],{"name":123,"affiliation":116,"role":124},[],[],{"nct_id":4,"conditions":241,"biomarkers":243},[242],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":245,"prompt_version":255},{"design":246,"status":247,"heading":248,"summary":249,"follow_up":250,"word_count":251,"commitments":252,"compensation":253,"drugs_mentioned":254},"This is an interventional study, meaning participants will receive specific treatments. It is a cohort study, not comparing different groups in a randomized way, and plans to enroll 318 participants.","completed","Real-World Outcomes of Pembrolizumab in Black Patients with Non-Small Cell Lung Cancer","This study is looking at how well different treatments work for Black patients with advanced non-small cell lung cancer (NSCLC). Researchers are studying the real-world outcomes of treatments that include pembrolizumab (an immunotherapy drug), often combined with chemotherapy drugs like cisplatin, carboplatin, pemetrexed, or Abraxane. You might be able to join if you are a Black adult, at least 18 years old, have advanced NSCLC that hasn't been treated before in this stage, and your cancer does not have certain genetic changes (EGFR, ALK, ROS1 mutations). The study will measure how long patients live overall and how long they live without their cancer getting worse, for up to 36 months. The study is currently unclear about its recruitment status and plans to enroll 318 participants.","Participants will be followed for up to 36 months to measure overall survival and progression-free survival.",125,"Not specified in the trial record.","Not stated in the trial record.",[32,38,41,44,49],"v2"]