Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06514118
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-03-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': '24 months', 'description': 'PFS: time to disease progression or patient death'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '36 months', 'description': 'OS: time to patient death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small-cell Lung Cancer', 'Residual Tumor', 'Radiation']}, 'descriptionModule': {'briefSummary': 'This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the progression-free survival (PFS) and overall survival of chemoimmunotherapy sequential residual tumor irradiation in patients with extensive stage small cell lung cancer (SCLC).\n\nSECONDARY OBJECTIVES:\n\nII. To assess the overall response rate (ORR) and toxicity in extensive stage SCLC patients treated with chemoimmunotherapy squential residual tumor irradiation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with extensive disease of small-cell lung cancer are enrolled and treated with chemotherapy plus PD-L1 immunotherapy for 4 cycles. Patients with esponse or stable disease are selected to receive residual lesions irratiation for 50GY/25f.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\>= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\\< 1 at the time of study treatment initiation Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in the contralateral lung, and/or the presence of extra-thoracic metastatic disease Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9/L Platelets \\>= 100 x 10\\^9/L Hemoglobin \\>= 9 g/dL Serum creatinine =\\< 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min.\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\< 3 x upper limit of normal (ULN) (ALT and AST =\\< 5 x ULN is acceptable if liver metastases are present) Total serum bilirubin =\\< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =\\< 3 x ULN with direct bilirubin within normal range.\n\nParticipant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment Patient has known hypersensitivity to the components of the study drugs or any analogs History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease. History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. Poorly controlled arrhythmias"}, 'identificationModule': {'nctId': 'NCT06514118', 'briefTitle': 'Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Qingdao Central Hospital'}, 'officialTitle': 'Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer', 'orgStudyIdInfo': {'id': 'KY202400902'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined chemotherapy and immunotherapy plus residual lesion irradiation', 'description': 'Patients receive carboplatin 5/AUC intravenously (IV) on day 1, adebrelimab 1200mg IV on day 1, and etoposide100mg/m2 IV on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity; redsidual tumor irradiation for 50GY in 25 fraction.', 'interventionNames': ['Radiation: residual tumor irradiation']}], 'interventions': [{'name': 'residual tumor irradiation', 'type': 'RADIATION', 'description': 'lung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total', 'armGroupLabels': ['Combined chemotherapy and immunotherapy plus residual lesion irradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'KEKE NIE, MD', 'role': 'CONTACT', 'email': 'NIEKEKEQD@163.COM', 'phone': '68665078'}], 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunhong You, MD', 'role': 'CONTACT', 'email': 'kevinji78@yahoo.com', 'phone': '18561857907'}], 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'youxin ji, md', 'role': 'CONTACT', 'phone': '86-532-68665078'}, {'name': 'youxin ji, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'chunling zhang, md', 'role': 'CONTACT', 'email': 'kevinji78@yahoo.com', 'phone': '1718865657'}], 'overallOfficials': [{'name': 'chunling zhang, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Qingdao Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qingdao Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Youxin Ji', 'investigatorAffiliation': 'Qingdao Central Hospital'}}}}