Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-10 @ 3:03 PM
Study NCT ID:
NCT03822351
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Sponsor:
Organization:
Raw JSON
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This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment', 'description': 'Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.', 'eventGroups': [{'id': 'EG000', 'title': 'Durvalumab Monotherapy', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 61, 'seriousNumAtRisk': 66, 'deathsNumAffected': 27, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Durvalumab + Oleclumab', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 52, 'seriousNumAtRisk': 59, 'deathsNumAffected': 23, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Durvalumab + Monalizumab', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 58, 'seriousNumAtRisk': 61, 'deathsNumAffected': 24, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '35.9'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '48.4'}, {'value': '40.3', 'groupId': 'OG002', 'lowerLimit': '28.1', 'upperLimit': '53.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint', 'description': 'ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \\>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group'}, {'type': 'SECONDARY', 'title': 'Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'Participants with any TEAEs', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any serious TEAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of signature of informed consent up to 15 months post the first dose of study treatment', 'description': 'The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received.'}, {'type': 'SECONDARY', 'title': 'Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'Participants with any Grade 3 or 4 Alanine Aminostransferase (U/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Albumin (g/dL) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Amylase (U/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Aspartate Aminotransferase (U/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Creatinine (mg/dL) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Creatinine Clearance Rate (mL/min) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Gamma Glutamyl Transferase (U/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Hyperkalemia (mEq/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Hypokalemia (mEq/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Hypocalcemia (corrected) (mg/dL) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Hypernatremia (mEq/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Lipase (U/L) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Hemoglobin increased (g/dL) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Lymphocyte count increased (10^3/uL) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Participants with any Grade 3 or 4 Platelet count decreased (10^3/uL) toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 15 months post the first dose of study treatment', 'description': 'The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received.'}, {'type': 'SECONDARY', 'title': 'Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Palpitations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 15 months post the first dose of study treatment', 'description': 'The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI could not be calculated as they were not reached.', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': 'NA'}, {'value': '29.9', 'comment': 'The upper limit of 95% CI could not be calculated as it was not reached.', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': 'NA'}, {'value': '23.0', 'comment': 'The upper limit of 95% CI could not be calculated as it was not reached.', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).', 'description': 'The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group. Only participants with an objective response were included in the DoR analysis.'}, {'type': 'SECONDARY', 'title': 'Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000', 'lowerLimit': '45.5', 'upperLimit': '70.2'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '89.2'}, {'value': '79.0', 'groupId': 'OG002', 'lowerLimit': '66.8', 'upperLimit': '88.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).', 'description': 'Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '13.8'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '30.9'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '31.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).', 'description': 'PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '50.4'}, {'value': '63.5', 'groupId': 'OG001', 'lowerLimit': '49.2', 'upperLimit': '74.7'}, {'value': '73.2', 'groupId': 'OG002', 'lowerLimit': '59.6', 'upperLimit': '82.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PFS rate at 12 months after randomization.', 'description': 'PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'comment': 'The upper limit of 95% CI could not be calculated as it was not reached.', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI could not be calculated as they were not reached.', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI could not be calculated as they were not reached.', 'groupId': 'OG002', 'lowerLimit': '31.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023).', 'description': 'OS was defined as the time from the date of randomization until death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'Cycle 1 Day 1: End of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '318.0', 'spread': '199.6', 'groupId': 'OG000'}, {'value': '277.4', 'spread': '316.1', 'groupId': 'OG001'}, {'value': '223.7', 'spread': '1272', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1: Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '58.6', 'groupId': 'OG000'}, {'value': '68.0', 'spread': '49.9', 'groupId': 'OG001'}, {'value': '74.3', 'spread': '40.7', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 7 Day 1: Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '151.6', 'spread': '37.7', 'groupId': 'OG000'}, {'value': '127.9', 'spread': '66.4', 'groupId': 'OG001'}, {'value': '176.5', 'spread': '45.6', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 11 Day 1: Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '156.7', 'spread': '50.0', 'groupId': 'OG000'}, {'value': '146.5', 'spread': '91.3', 'groupId': 'OG001'}, {'value': '172.4', 'spread': '40.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK-evaluable durvalumab population included participants from the As-treated population who had a non-missing baseline PK durvalumab concentration and at least one non-missing post-baseline PK durvalumab concentration'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Novel Agents in Combination With Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG001', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'Cycle 1 Day 1: End of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '581.6', 'spread': '210.5', 'groupId': 'OG000'}, {'value': '160.0', 'spread': '286.4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '216.4', 'spread': '58.6', 'groupId': 'OG000'}, {'value': '102.6', 'spread': '39.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1: Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.5', 'spread': '109.0', 'groupId': 'OG000'}, {'value': '194.5', 'spread': '33.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11 Day 1: Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.0', 'spread': '166.8', 'groupId': 'OG000'}, {'value': '196.2', 'spread': '48.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK-evaluable oleclumab/monalizumab population included participants from the As-treated population who had a non-missing baseline PK oleclumab/monalizumab concentration and at least one non-missing post-baseline PK oleclumab/monalizumab concentration'}, {'type': 'SECONDARY', 'title': 'Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'OG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'ADA positive at any visit (ADA prevalence)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-emergent ADA positive (ADA incidence)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-induced ADA (positive post-baseline only)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ADA positive at baseline only', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ADA positive post-baseline and positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Persistently positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Transiently positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.\n\nADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The durvalumab ADA-evaluable population included participants from the As-treated population who had a non-missing baseline durvalumab ADA result and at least one non-missing post-baseline durvalumab ADA result'}, {'type': 'SECONDARY', 'title': 'Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'OG001', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'classes': [{'title': 'ADA positive at any visit (ADA prevalence)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-emergent ADA positive (ADA incidence)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-induced ADA (positive post-baseline only)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive at baseline only', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive post-baseline and positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Persistently positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Transiently positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.\n\nADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The oleclumab/monalizumab ADA-evaluable population included participants from the As-treated population who had a non-missing baseline oleclumab/monalizumab ADA result and at least one non-missing post-baseline oleclumab/monalizumab ADA result'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'FG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'FG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The first participant was randomized into the study on 3 January 2019 and the last participant was randomized on 6 July 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Arm (Durvalumab Monotherapy)', 'description': 'Durvalumab 1500 mg IV monotherapy Q4W'}, {'id': 'BG001', 'title': 'Arm A (Durvalumab + Oleclumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)'}, {'id': 'BG002', 'title': 'Arm B (Durvalumab + Monalizumab)', 'description': 'Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '64.6', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Hong-Kong', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-27', 'size': 3148593, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-23T03:16', 'hasProtocol': True}, {'date': '2023-09-04', 'size': 1215301, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-23T03:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.\n\nStudy treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2018-12-10', 'resultsFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-04', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'timeFrame': 'ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint', 'description': 'ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \\>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.'}], 'secondaryOutcomes': [{'measure': 'Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents', 'timeFrame': 'From time of signature of informed consent up to 15 months post the first dose of study treatment', 'description': 'The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events'}, {'measure': 'Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents', 'timeFrame': 'From baseline up to 15 months post the first dose of study treatment', 'description': 'The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values'}, {'measure': 'Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents', 'timeFrame': 'From baseline up to 15 months post the first dose of study treatment', 'description': 'The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events'}, {'measure': 'Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'timeFrame': 'Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).', 'description': 'The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR'}, {'measure': 'Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'timeFrame': 'Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).', 'description': 'Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1.'}, {'measure': 'Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'timeFrame': 'Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).', 'description': 'PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first'}, {'measure': 'Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'timeFrame': 'PFS rate at 12 months after randomization.', 'description': 'PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization.'}, {'measure': 'Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents', 'timeFrame': 'From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023).', 'description': 'OS was defined as the time from the date of randomization until death due to any cause.'}, {'measure': 'Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate.'}, {'measure': 'Pharmacokinetics of Novel Agents in Combination With Durvalumab', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate.'}, {'measure': 'Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.\n\nADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.'}, {'measure': 'Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab', 'timeFrame': 'From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1', 'description': 'ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.\n\nADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally Advanced NSCLC', 'Non-small Cell Lung Cancer', 'Cancer', 'Lung', 'Unresectable', 'Stage III'], 'conditions': ['Stage III Non-small Cell Lung Cancer', 'Unresectable']}, 'referencesModule': {'references': [{'pmid': '40663352', 'type': 'DERIVED', 'citation': 'Aggarwal C, Martinez-Marti A, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Pillet M, Brown M, Paliompeis C, Dowson A, Cooper ZA, Kumar R, Herbst RS. Durvalumab Alone or Combined With Novel Agents for Unresectable Stage III Non-Small Cell Lung Cancer: Update From the COAST Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518440. doi: 10.1001/jamanetworkopen.2025.18440.'}, {'pmid': '35452273', 'type': 'DERIVED', 'citation': 'Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 10;40(29):3383-3393. doi: 10.1200/JCO.22.00227. Epub 2022 Apr 22.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9108C00001&attachmentIdentifier=de7dfeb7-8334-4784-8d4a-da8d429556aa&fileName=d9108c00001-csp-amendment-4_Redacted.pdf&versionIdentifier=', 'label': 'CSP redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9108C00001&attachmentIdentifier=51d2c3e5-8514-4a79-907b-da0a3149d00c&fileName=D9108C00001_Statistical_Analysis_Plan_v5_Redacted.pdf&versionIdentifier=', 'label': 'SAP redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9108C00001&attachmentIdentifier=f0bb70f9-6f4e-4554-b7e4-aafad3298d36&fileName=d9108c00001-study-synopsis_Redacted.pdf&versionIdentifier=', 'label': 'CSR Synopsis redacted'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.', 'detailedDescription': 'Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation\n2. Age 18 years or older\n3. Body weight ≥ 35 kg\n4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease\n5. Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study\n6. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy\n7. Life expectancy ≥ 12 weeks\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n9. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1\n\nMain Exclusion Criteria:\n\n1. Mixed small cell and non-small cell lung cancer histology\n2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug\n3. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC\n4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy\n5. Subjects with a history of venous thrombosis within the past 3 months\n6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months\n7. Congestive heart failure\n8. Active or prior documented autoimmune or inflammatory disorders\n9. History of active primary immunodeficiency\n10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)\n11. History of allogenic organ transplantation\n12. QTcF interval ≥ 470 ms\n13. History of another primary malignancy\n14. Concurrent enrollment in another clinical study \\[concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted\\]\n15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study'}, 'identificationModule': {'nctId': 'NCT03822351', 'acronym': 'COAST', 'briefTitle': 'Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)', 'orgStudyIdInfo': {'id': 'D9108C00001'}, 'secondaryIdInfos': [{'id': '2018-002931-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Arm (Durvalumab monotherapy)', 'description': 'durvalumab IV', 'interventionNames': ['Drug: Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A (durvalumab + oleclumab):', 'description': 'durvalumab IV 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