Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 6:02 PM
Study NCT ID:
NCT04550260
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-16
First Post:
2020-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Netherlands', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C095424', 'term': 'CF regimen'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor, excluding supply chain management personnel, will remain blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'up to approximately 72 months', 'description': 'To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC'}], 'primaryOutcomes': [{'measure': 'Progression free survival (PFS) per RECIST 1.1 as assessed by BICR', 'timeFrame': 'up to approximately 56 months', 'description': 'To assess the efficacy in terms of PFS in PD-L1 High population'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'up to approximately 72 months', 'description': 'To assess the efficacy in terms of OS in all randomized patients and in PD-L1 High population until the date of death'}, {'measure': 'Progression free survival (PFS) per RECIST 1.1 as assessed by BICR', 'timeFrame': 'up to approximately 56 months', 'description': 'To assess the efficacy in terms of PFS in all randomized patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally Advanced unresectable ESCC', 'PD-L1', 'Durvalumab'], 'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).', 'detailedDescription': 'Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older at the time of signing the ICF.\n* Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).\n* Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.\n* Patients with at least an evaluable lesion per RECIST 1.1.\n* Mandatory provision of available tumor tissue for PD-L1 expression analysis.\n* ECOG PS 0 or 1.\n* Adequate organ and marrow function.\n* Life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.\n* Prior anti-cancer treatment for ESCC.\n* Patient with a great risk of perforation and massive bleeding.\n* History of allogeneic organ transplantation.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Uncontrolled intercurrent illness.\n* History of another primary malignancy.\n* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.'}, 'identificationModule': {'nctId': 'NCT04550260', 'acronym': 'KUNLUN', 'briefTitle': 'Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)', 'orgStudyIdInfo': {'id': 'D910SC00001'}, 'secondaryIdInfos': [{'id': '2020-001001-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Durvalumab + definitive CRT', 'description': 'Durvalumab + concurrent chemoradiation', 'interventionNames': ['Drug: Durvalumab', 'Drug: cisplatin + fluorouracil', 'Drug: cisplatin + capecitabine', 'Radiation: Radiation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Placebo + definitive CRT', 'description': 'Placebo + concurrent chemoradiation', 'interventionNames': ['Drug: Placebo', 'Drug: cisplatin + fluorouracil', 'Drug: cisplatin + capecitabine', 'Radiation: Radiation']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Durvalumab intravenous infusion', 'armGroupLabels': ['Arm 1: 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