Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT06357533
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2024-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Open-label, sponsor-blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 675}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-05-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety of Dato-DXd in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab.', 'timeFrame': 'Approximately 6 years', 'description': 'Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0).'}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) in TROP2 biomarker positive participants.', 'timeFrame': 'Approximately 4 years', 'description': 'PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.\n\nThe analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population:\n\n• TROP2 biomarker positive population\n\nThe measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.'}, {'measure': 'Overall Survival (OS) in TROP2 biomarker positive participants.', 'timeFrame': 'Approximately 6 years', 'description': 'OS is defined as the time from randomisation until the date of death due to any cause.\n\nThe analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population:\n\n• TROP2 biomarker positive population The measure of interest is the HR of OS.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) in the FAS population.', 'timeFrame': 'Approximately 4 years', 'description': 'PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.\n\nThe analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population:\n\n• FAS population\n\nThe measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.'}, {'measure': 'Overall Survival (OS) in the FAS population.', 'timeFrame': 'Approximately 6 years', 'description': 'OS is defined as the time from randomisation until the date of death due to any cause.\n\nThe analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population:\n\n• FAS population The measure of interest is the HR of OS.'}, {'measure': 'Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations', 'timeFrame': 'Approximately 4 years', 'description': 'ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR per RECIST 1.1.\n\nThe analyses will include all randomised participants, as randomised, with measurable disease at baseline, in the following populations:\n\n* TROP2 biomarker positive population\n* FAS population Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR.\n\nThe measure of interest is the OR of the ORR. ORR by investigator will be reported as a sensitivity analysis.'}, {'measure': 'Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations', 'timeFrame': 'Approximately 4 years', 'description': 'DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR and investigator assessment or death due to any cause.\n\nThe analyses will include all randomised participants who have a response, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following populations:\n\n* TROP2 biomarker positive population\n* FAS population The measure of interest is the median of DoR. DoR by investigator will be reported as a sensitivity analysis.'}, {'measure': 'Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab.', 'timeFrame': 'Approximately 6 years', 'description': 'Time to deterioration in: pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ, in overall lung cancer symptoms as measured by the NSCLC-SAQ, and in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172.\n\nTime to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations:\n\n* TROP2 biomarker positive population\n* FAS population The measure of interest is the HR of time to deterioration in pulmonary symptoms, HR of time to deterioration in overall lung cancer symptoms, and HR of time to deterioration in GHS/QoL.'}, {'measure': 'Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.', 'timeFrame': 'Approximately 6 years', 'description': 'Time to deterioration in physical functioning as measured by PROMIS Physical Function short form 8c.\n\nTime to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations:\n\n* TROP2 biomarker positive population\n* FAS population The measure of interest is the HR of time to deterioration in physical functioning.'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': 'Approximately 6 years', 'description': 'Concentration of rilvegostomig, Dato-DXd, total anti TROP2 antibody, and MAAA 1181a (payload deruxtecan) in plasma or serum and PK parameters (peak and trough concentrations).'}, {'measure': 'Immunogenicity', 'timeFrame': 'Approximately 6 years', 'description': 'Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).'}, {'measure': 'Second Progression-Free Survival (PFS2).', 'timeFrame': 'Approximately 6 years', 'description': 'PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death. Progression event includes radiological (RECIST 1.1) or clinical disease progression.\n\nThe date of second progression will be recorded by the investigator in the eCRF and defined according to local standard practice.\n\nThe analyses will include all randomised participants, as randomised, regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits, in the following populations:\n\n* TROP2 biomarker positive population\n* FAS population The measure of interest is the HR of PFS2.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'Non-Small Cell Lung Cancer', 'Datopotamab Deruxtecan', 'Rilvegostomig', 'Pembrolizumab', 'Non-squamous', 'PD-L1 expression >=50%', 'Locally-advanced NSCLC', 'Metastatic NSCLC'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.', 'detailedDescription': 'This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy versus Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented non-squamous NSCLC.\n* Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.\n* Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.\n* Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.\n* Known tumour PD-L1 expression status defined as TC ≥ 50%\n* At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline\n* ECOG performance status of 0 or 1\n* Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention\n\nExclusion Criteria:\n\n* Prior systemic therapy for advanced/metastatic NSCLC.\n* Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.\n* History of another primary malignancy within 3 years\n* Active or prior documented autoimmune or inflammatory disorders (with exceptions)\n* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.\n* Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.\n* History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening\n* Has significant pulmonary function compromise, as determined by the investigator\n* Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.\n* History of leptomeningeal carcinomatosis\n* Known clinically significant corneal disease\n* Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled\n* History of active primary immunodeficiency'}, 'identificationModule': {'nctId': 'NCT06357533', 'acronym': 'TROPION-Lung10', 'briefTitle': 'Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)', 'orgStudyIdInfo': {'id': 'D7632C00001'}, 'secondaryIdInfos': [{'id': '2023-505077-32-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig', 'description': 'Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.', 'interventionNames': ['Drug: Datopotamab Deruxtecan', 'Drug: Rilvegostomig']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Rilvegostomig Monotherapy', 'description': 'Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.', 'interventionNames': ['Drug: Rilvegostomig']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3: Pembrolizumab Monotherapy', 'description': 'Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Datopotamab Deruxtecan', 'type': 'DRUG', 'otherNames': ['Dato-DXd'], 'description': 'Datopotamab Deruxtecan IV (intravenous)', 'armGroupLabels': ['Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig']}, {'name': 'Rilvegostomig', 'type': 'DRUG', 'otherNames': ['AZD2936'], 'description': 'Rilvegostomig IV (intravenous)', 'armGroupLabels': ['Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig', 'Arm 2: Rilvegostomig Monotherapy']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA'], 'description': 'Pembrolizumab IV (intravenous)', 'armGroupLabels': ['Arm 3: Pembrolizumab Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 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'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'SUSPENDED', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '46062', 'city': 'Noblesville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.04559, 'lon': -86.0086}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '59715', 'city': 'Bozeman', 'state': 'Montana', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '68803', 'city': 'Grand Island', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.92501, 'lon': -98.34201}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 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States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43551', 'city': 'Perrysburg', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.557, 'lon': -83.62716}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': 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