Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:27 AM
Study NCT ID:
NCT07434518
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood mononuclear cells, tumor tissue, lymph node tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune-related adverse events', 'timeFrame': 'Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.', 'description': 'The incidence of grade ≥3 immune-related adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From enrollment to the end of treatment at 12 months.', 'description': 'The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. Record the survival （days） post first Adebrelimab Treatment.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From enrollment to the end of treatment at 12 months.]', 'description': 'The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes progression-free survival (PFS) days post Adebrelimab treatment.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'From enrollment to the end of treatment at 12 months.', 'description': 'The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Objective response rate (ORR) post Adebrelimab treatment.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'From enrollment to the end of treatment at 12 months.', 'description': 'The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Disease control rate (DCR) post Adebrelimab treatment.'}, {'measure': 'The density of immune cells in peripheral blood before and after treatment', 'timeFrame': 'From enrollment to the end of treatment at 90 days.', 'description': 'Although PD-L1 expression is currently a recognized predictive biomarker for efficacy, its predictive value varies significantly across different tumor types, detection platforms, and cutoff thresholds. Real-world data can be utilized through multi-omics integrated analysis (such as genomics, transcriptomics, and immune microenvironment characteristics) to identify novel biomarkers. We will measure immune cell density in peripheral blood before and after treatment, to determine whether they correlate with clinical response. This could provide a non-invasive approach for monitoring treatment efficacy.'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.', 'description': 'The incidence of adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.'}, {'measure': 'Incidence of Serious Adverse Events', 'timeFrame': 'Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.', 'description': 'The incidence of serious adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'efficacy', 'SCLC'], 'conditions': ['Small Cell Lung Cancer (SCLC)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are:\n\n1. The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.\n2. Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer;\n* Age ≥ 18 years;\n* The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.\n\nExclusion Criteria:\n\n* Patients concurrently receiving other immune-modulating drugs or therapies;\n* Patients currently participating in other interventional studies;\n* Patients with concurrent other malignancies;\n* Patients with missing key study-related data.'}, 'identificationModule': {'nctId': 'NCT07434518', 'briefTitle': 'A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '20250704064933814'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adebrelimab (PD-L1 inhibitor)', 'type': 'BIOLOGICAL', 'description': 'Investigating the efficacy and long-term safety of adebrelimab in different subgroups of SCLC patients (e.g., elderly patients, patients with comorbidities) in a real-world setting.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201620', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanghai General Hospital', 'role': 'CONTACT', 'email': 'shiyicss@126.com', 'phone': '86-021-63240090'}], 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qingnan Zhao, PhD', 'role': 'CONTACT', 'email': 'zhaoqingnan2010@126.com', 'phone': '+86 (021)37798597'}, {'name': 'Qian Xue, PhD', 'role': 'CONTACT', 'phone': '+86 (021)37798597'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}, {'name': 'Shanghai Chest Hospital of Shanghai Jiao Tong University', 'class': 'OTHER'}, {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Tongji Hospital, Tongji University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr./Chief Physician, Thoracic Surgery', 'investigatorFullName': 'Zheng Ruan', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}