Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT07272057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibitors and Survival in Lung Cancer Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with death', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with new-onset atrial fibrillation/flutter, acute coronary syndrome, myocarditis, massive pericardial effusion, heart failure and third-degree atrioventricular block.', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial\n\nThe goal of this clinical trial is to evaluate whether SGLT2 inhibitor drugs can extend overall survival or delay the progression of the tumor in patients with both advanced lung cancer and diabetes. It will also check if these drugs are safe for these patients. The main questions it aims to answer are:\n\n* Does adding an SGLT2 inhibitor to standard cancer treatment improve survival?\n* Does it cause more or fewer cardiovascular toxicity?\n* What side effects do participants experience? Researchers will compare a group taking an SGLT2 inhibitor to a group not taking SGLT2 inhibitor to see if the drug works.\n\nParticipants will:\n\n* Be adults diagnosed with advanced lung cancer and type 2 diabetes.\n* Take either the SGLT2 inhibitor pill or other hypoglycemic drugs once a day alongside their cancer treatment.\n* Undergo regular clinical visits for monitoring, laboratory tests, and imaging studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Lung cancer patients receiving standard anti-tumor treatment; type 2 diabetes; patients with a score of 0-2 assessed by Eastern Cooperative Oncology Group's performance status; the patients agreed to participate in this study.\n\nExclusion Criteria:\n\n* Severe abnormalities in liver, kidney or heart functions; expected lifespan less than 3 months."}, 'identificationModule': {'nctId': 'NCT07272057', 'briefTitle': 'SGLT2 Inhibitors and Survival in Lung Cancer Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'The Impact of SGLT2i on the Outcome of Advanced Lung Cancer in Patients With Diabetes', 'orgStudyIdInfo': {'id': 'SLC-DO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'On the basis of standard cancer treatment, take dapagliflozin for at least three months, once a day, 10 mg each time.', 'interventionNames': ['Drug: SGLT-2 inhibitor']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'Based on the standard treatment for tumors, for the treatment of diabetes, no dapagliflozin has been taken.', 'interventionNames': ['Other: Sham (No Treatment)']}], 'interventions': [{'name': 'SGLT-2 inhibitor', 'type': 'DRUG', 'description': 'SGLT2 inhibitors used for patients with lung cancer and diabetes', 'armGroupLabels': ['treatment group']}, {'name': 'Sham (No Treatment)', 'type': 'OTHER', 'description': 'SGLT2 inhibitors are not used for patients with lung cancer and diabetes', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jindong Chen', 'role': 'CONTACT', 'email': 'cjdxk2016@163.com', 'phone': '+862122200000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Liang Zhao', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}