Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT05211895
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Russia']}, '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': 'C000613593', 'term': 'durvalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 860}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 8 years after randomization', 'description': 'Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 8 years after randomization', 'description': 'Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1%'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Overall Survival (OS)'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Duration of Response (DoR) using BICR assessment according to RECIST 1.1'}, {'measure': 'Time from randomization to second progression (PFS2)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Time from randomization to second progression (PFS2)'}, {'measure': 'Time from randomization to first date of distant metastasis or death (TTDM)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).'}, {'measure': 'Time to first subsequent therapy (TFST)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Time to first subsequent therapy (TFST)'}, {'measure': 'Concentration of Durvalumab and Domvanalimab', 'timeFrame': 'Approximately 12 weeks after last IP dose', 'description': 'The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration'}, {'measure': 'PFS6, PFS12, PFS18, PFS24', 'timeFrame': 'Approximately 6, 12, 18 and 24 months after randomization', 'description': 'PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier)'}, {'measure': 'Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Approximately 12 weeks after last IP dose.', 'description': 'The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs)'}, {'measure': 'Time to deterioration in pulmonary symptoms (TTFCD)', 'timeFrame': 'Approximately 8 years after randomization', 'description': 'Time to deterioration in pulmonary symptoms (TTFCD)'}, {'measure': 'PFS investigator', 'timeFrame': 'Up to 8 years after randomization', 'description': 'Defined as time from randomisation until progression per RECIST 1.1 as assessed by Investigator or death due to any cause in participants'}, {'measure': 'OS 24', 'timeFrame': 'Approximately 24 months after randomization', 'description': 'Overall Survival (OS) at 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'locally advanced', 'NSCLC'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.lungcancerstudylocator.com/trial/listing/331601', 'label': '1-844-432-3892 Lung Cancer Study Locator details to CT.gov for the US sites only'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n1. Participant must be ≥ 18 years at the time of screening.\n2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease\n3. Provision of a tumour tissue sample obtained prior to CRT\n4. Documented tumour PD-L1 status ≥ 1% by central lab\n5. Documented EGFR and ALK wild-type status (local or central).\n6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy\n7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy\n8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.\n9. WHO performance status of 0 or 1 at randomization\n10. Adequate organ and marrow function\n\nEXCLUSION CRITERIA:\n\n1. History of another primary malignancy, except for:\n\n * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.\n * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .\n * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.\n2. Mixed small cell and non-small cell lung cancer histology.\n3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.\n4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.\n5. Any unresolved toxicity CTCAE \\>Grade 2 from the prior chemoradiation therapy (excluding alopecia).\n6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.\n7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis\n8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)\n9. Active EBV infection, or known or suspected chronic active EBV infection at screening\n10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.'}, 'identificationModule': {'nctId': 'NCT05211895', 'acronym': 'PACIFIC-8', 'briefTitle': 'A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy', 'orgStudyIdInfo': {'id': 'D9075C00001'}, 'secondaryIdInfos': [{'id': '2021-004327-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Durvalumab + Domvanalimab', 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