[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07291037":3,"trial-entities:NCT07291037":1325,"trial-summary:NCT07291037":1330},{"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":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":49,"secondary_outcomes":58,"sex":95,"minimum_age":96,"maximum_age":97,"healthy_volunteers":98,"eligibility_criteria":99,"std_ages":123,"locations":126,"central_contacts":1316,"overall_officials":1322,"references":1323,"see_also_links":1324},"NCT07291037","D763QC00001","Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations","A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)","RECRUITING","2029-01-29","2026-06","2026-07-01","2025-10-31","AstraZeneca","INDUSTRY",true,"TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).","TROPION-Lung17 is a phase III, 2-arm, randomised, open-label, multicentre study, assessing the efficacy and safety of Dato-DXd compared with docetaxel in participants with previously treated trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), and to assess the clinical performance of the investigational in vitro diagnostic (IVD) device.",[19],"Non-small Cell Lung Cancer (NSCLC)",[21,22,23,24,25,26,27,28],"TROPION-Lung17","Non-small cell lung cancer (NSCLC)","Advanced non-squamous NSCLC","Metastatic non-squamous NSCLC","Datopotamab deruxtecan (Dato-DXd; DS-1062a)","Docetaxel","Trophoblast cell surface protein 2 (TROP2)","Normalised membrane ratio (NMR)","INTERVENTIONAL","TREATMENT",[32],"PHASE3",{"count":34,"type":35},400,"ESTIMATED",[37,45],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":43},"DRUG","Datopotamab deruxtecan (Dato-DXd)","Dato-DXd administered intravenously (IV)",[42],"Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy",[44],"DS-1062a",{"type":38,"name":26,"description":46,"armGroupLabels":47},"Docetaxel administered intravenously (IV)",[48],"Arm B: Docetaxel monotherapy",[50,54],{"measure":51,"description":52,"timeFrame":53},"Progression-free survival (PFS)","PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), or death due to any cause.","Approximately 2.5 years",{"measure":55,"description":56,"timeFrame":57},"Overall survival (OS)","OS is defined as the time from randomization until the date of death due to any cause.","Approximately 3.5 years",[59,62,65,68,71,74,77,80,83,86,89,92],{"measure":60,"description":61,"timeFrame":53},"Objective response rate (ORR)","ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).",{"measure":63,"description":64,"timeFrame":53},"Duration of response (DoR)","DoR is defined as the time from the date of first documented response until the date of documented progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR) or death due to any cause.",{"measure":66,"description":67,"timeFrame":53},"Time to second progression or death (PFS2)","PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after first subsequent therapy, or death. The date of the second progression will be recorded by the Investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice based on radiological or clinical progression.",{"measure":69,"description":70,"timeFrame":53},"Exposure-efficacy relationship","Evaluate the relationship between plasma concentrations of Dato-DXd (µg\u002FmL) and efficacy endpoints (PFS, OS), as evaluated by cox-proportional hazard model.",{"measure":72,"description":73,"timeFrame":53},"Exposure-safety relationship","Evaluate the correlation between concentrations of Dato-DXd (µg\u002FmL) and safety endpoints (including Gr3+AE, AESIs), as evaluated by logistic regression",{"measure":75,"description":76,"timeFrame":53},"Covariates effect on exposure","Evaluate the relationship between covariates (including but not limited to age, sex, body weight, race) and plasma concentrations of Dato-DXd (µg\u002FmL) and\u002For DXd (ng\u002FmL), as evaluated by population PK model",{"measure":78,"description":79,"timeFrame":53},"Immunogenicity of datopotamab deruxtecan (Dato-DXd)","Presence of antidrug antibodies (ADAs) for Dato-DXd.",{"measure":81,"description":82,"timeFrame":53},"Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)","Time to deterioration (TTD) in pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ).\n\nScores range from a minimum of 0 to a maximum of 20, with higher scores indicating more symptom burden.\n\nTTD is defined as time from randomization to the date of first deterioration.\n\nDeterioration is defined as change from baseline that reaches an meaningful change threshold (MCT).",{"measure":84,"description":85,"timeFrame":53},"Participant-reported physical functioning","Time to deterioration (TTD) in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Physical Function 8c.\n\nTTD is defined as time from randomization to the date of first deterioration.\n\nDeterioration is defined as change from baseline that reaches a meaningful change threshold (MCT).",{"measure":87,"description":88,"timeFrame":53},"Participant-reported global health status (GHS)\u002Fquality of life (QoL)","Time to deterioration (TTD) in GHS\u002FQoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172).\n\nScores range from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.\n\nTTD is defined as time from the date of randomisation to the date of first deterioration.\n\nDeterioration is defined as change from baseline that reaches a meaningful change threshold (MCT).",{"measure":90,"description":91,"timeFrame":53},"Correlation of TROP2 expression at various cut offs with clinical response","Evaluate the relationship between TROP2 NMR expression and efficacy endpoints.",{"measure":93,"description":94,"timeFrame":53},"Diagnostic development and biomarker assay concordance analysis","Evaluate the relationship between TROP2 NMR status at a defined cutoff and efficacy endpoints, as determined by the diagnostic device.","ALL","18 Years",null,false,{"inclusion":100,"exclusion":111,"raw_text":122},[101,102,103,104,105,106,107,108,109,110],"Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:","Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.","Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.","Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.","Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.","Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)\u002Fanti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1\u002Fanti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.","Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.","At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.","Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.","Adequate bone marrow reserve and organ function within 7 days before randomisation.",[112,113,114,115,116,117,118,119,120,121],"Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.","NSCLC disease that is eligible for definitive local therapy alone.","History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.","Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.","Clinically significant corneal disease.","Has active or uncontrolled hepatitis B or C virus infection.","Known human immunodeficiency virus (HIV) infection that is not well controlled.","Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.","History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.","Severe pulmonary function compromise per Investigator discretion.","Inclusion Criteria:\n\n* Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:\n\n  * Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.\n  * Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.\n  * Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.\n* Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.\n* Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)\u002Fanti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1\u002Fanti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.\n* Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.\n* At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Adequate bone marrow reserve and organ function within 7 days before randomisation.\n\nExclusion Criteria:\n\n* Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.\n* NSCLC disease that is eligible for definitive local therapy alone.\n* History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.\n* Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.\n* Clinically significant corneal disease.\n* Has active or uncontrolled hepatitis B or C virus infection.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Severe pulmonary function compromise per Investigator discretion.",[124,125],"ADULT","OLDER_ADULT",[127,136,142,148,155,161,167,173,180,186,193,199,206,213,220,226,232,238,244,251,257,264,267,273,279,286,293,300,306,313,320,327,334,341,348,355,362,369,376,382,389,396,403,409,415,422,428,434,441,448,455,462,468,474,480,486,493,499,505,511,514,521,527,530,536,542,549,552,558,564,567,570,578,585,592,599,605,611,618,621,624,630,636,642,645,651,657,663,669,675,681,687,693,699,705,711,714,717,723,729,735,741,744,750,756,759,766,772,778,784,790,797,803,809,815,821,827,833,839,845,851,857,863,869,875,881,887,894,897,900,903,909,912,918,924,930,936,942,949,955,961,967,973,980,983,989,995,1001,1007,1014,1020,1026,1029,1035,1038,1044,1050,1056,1062,1068,1071,1077,1080,1086,1093,1099,1105,1111,1118,1124,1130,1133,1136,1142,1149,1155,1161,1167,1173,1179,1185,1192,1198,1204,1210,1213,1216,1222,1229,1232,1235,1241,1244,1251,1257,1264,1270,1273,1276,1282,1288,1294,1301,1307,1310],{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Research 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Columbia","20037",{"lat":211,"lon":212},38.89511,-77.03637,{"facility":128,"status":8,"city":214,"state":215,"zip":216,"country":132,"geoPoint":217},"Fort Myers","Florida","33901",{"lat":218,"lon":219},26.62168,-81.84059,{"facility":128,"status":8,"city":221,"state":215,"zip":222,"country":132,"geoPoint":223},"Jacksonville","32224",{"lat":224,"lon":225},30.33218,-81.65565,{"facility":128,"status":8,"city":227,"state":215,"zip":228,"country":132,"geoPoint":229},"St. Petersburg","33709",{"lat":230,"lon":231},27.77086,-82.67927,{"facility":128,"status":8,"city":233,"state":215,"zip":234,"country":132,"geoPoint":235},"Tampa","33612",{"lat":236,"lon":237},27.94752,-82.45843,{"facility":128,"status":8,"city":239,"state":215,"zip":240,"country":132,"geoPoint":241},"West Palm Beach","33401",{"lat":242,"lon":243},26.71534,-80.05337,{"facility":128,"status":8,"city":245,"state":246,"zip":247,"country":132,"geoPoint":248},"Marietta","Georgia","30060",{"lat":249,"lon":250},33.9526,-84.54993,{"facility":128,"status":8,"city":252,"state":246,"zip":253,"country":132,"geoPoint":254},"Newnan","30265",{"lat":255,"lon":256},33.38067,-84.79966,{"facility":128,"status":8,"city":258,"state":259,"zip":260,"country":132,"geoPoint":261},"Chicago","Illinois","60612",{"lat":262,"lon":263},41.85003,-87.65005,{"facility":128,"status":8,"city":258,"state":259,"zip":265,"country":132,"geoPoint":266},"60637",{"lat":262,"lon":263},{"facility":128,"status":8,"city":268,"state":259,"zip":269,"country":132,"geoPoint":270},"Niles","60714",{"lat":271,"lon":272},42.01892,-87.80284,{"facility":128,"status":8,"city":274,"state":259,"zip":275,"country":132,"geoPoint":276},"Zion","60099",{"lat":277,"lon":278},42.44613,-87.83285,{"facility":128,"status":8,"city":280,"state":281,"zip":282,"country":132,"geoPoint":283},"Louisville","Kentucky","40207",{"lat":284,"lon":285},38.25424,-85.75941,{"facility":128,"status":8,"city":287,"state":288,"zip":289,"country":132,"geoPoint":290},"South 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It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.","completed","Phase III Study for TROP2-positive Advanced Lung Cancer","This study is testing a drug called datopotamab deruxtecan (Dato-DXd) against a standard chemotherapy drug, docetaxel, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This is for lung cancer that has already been treated and is TROP2-positive, meaning it has a specific protein on the cancer cells. You might be able to join if you have Stage IIIB, IIIC, or Stage IV non-squamous NSCLC without certain genetic changes (actionable genomic alterations like EGFR, ALK, ROS1). The study aims to see if Dato-DXd can help people live longer without their cancer getting worse (progression-free survival) and if it helps them live longer overall (overall survival). The study is planned to include about 400 participants, but its current status is unclear.","The study will follow participants for progression-free survival for approximately 2.5 years and overall survival for approximately 3.5 years.",122,"Not specified in the trial record.","Not stated in the trial record.",[39,26],"v2"]