Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT04870112
Status:
TERMINATED
Last Update Posted:
2025-04-17
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Czechia', 'Singapore', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of injection site reactions reported through ISQ Symptoms questionnaire', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Treatment satisfaction reported using ISQ Satisfaction questionnaire', 'timeFrame': 'Approximately 16 months'}], 'primaryOutcomes': [{'measure': 'Observed serum concentration (Ctrough)', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Number of patients with injection site reactions and immune-mediated reactions', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Maximum observed serum concentration (Cmax)', 'timeFrame': 'Approximately 16 months'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed serum concentration (tmax) of durvalumab', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Changes in WHO/ECOG performance status', 'timeFrame': 'Approximately 16 months'}, {'measure': "Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals", 'timeFrame': 'Approximately 16 months'}, {'measure': 'Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry', 'timeFrame': 'Approximately 16 months', 'description': 'Clinical chemistry will be assessed by liver function(Alanine aminotransferase, Aspartate aminotransferase, albumin, total bilirubin), kidney function (e.g. Urea, Creatinine) and endocrine function(TSH, T3 free,T4 free)'}, {'measure': 'Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology', 'timeFrame': 'Approximately 16 months', 'description': 'Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.'}, {'measure': 'Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (pulse rate) in beats per minute', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (respiration rate) in breaths per minute', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies', 'timeFrame': 'Approximately 16 months'}, {'measure': 'Part 2 only: Overall Response Rate (ORR) - proportion of participants with a complete or partial response to treatment as determined using RECIST 1.1 guidelines', 'timeFrame': 'Approximately 16 months'}, {'measure': "Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug", 'timeFrame': 'Approximately 16 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['imfinzi', 'durvalumab'], 'conditions': ['Non-Small Cell Lung Cancer', 'Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astrazenecaclinicaltrials.com/study/D9072C00001/', 'label': 'AstraZenecaClinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'This study has 2 parts: dose finding and dose confirmatory.\n\nIn Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up\n\nIn Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period.\n\nAstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC\n* ECOG performance status of 0 or 1\n* For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline\n* Absence of EGFR mutation or ALK rearrangement prior to screening\n\nExclusion Criteria:\n\n* History of allogeneic organ transplantation\n* Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome\n* Uncontrolled intercurrent illness\n* History of another primary malignancy\n* History of active primary immunodeficiency\n* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)\n* Brain metastases or spinal cord compression\n* Persistent toxicities (CTCAE Grade \\>2) caused by previous anticancer therapy, excluding alopecia\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP'}, 'identificationModule': {'nctId': 'NCT04870112', 'acronym': 'SCope-D1', 'briefTitle': 'A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1', 'orgStudyIdInfo': {'id': 'D9072C00001'}, 'secondaryIdInfos': [{'id': '2020-006041-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with NSCLC', 'description': 'Patients with Non-Small Cell Lung Cancer', 'interventionNames': ['Drug: Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with SCLC', 'description': 'Patients with Small Cell Lung Cancer', 'interventionNames': ['Drug: Durvalumab', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736, IMFINZI'], 'description': 'Anti-PD-L1 antibody', 'armGroupLabels': ['Patients with NSCLC', 'Patients with SCLC']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Patients with SCLC']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Patients with SCLC']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Patients with SCLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Suli Bolus, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}