Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 5:49 PM
Study NCT ID:
NCT07035860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tumor tissue, blood, urine, and stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarker Analysis', 'timeFrame': '36 months', 'description': 'Including ctDNA levels and their correlation with treatment response; additional biomarkers include PD-L1 expression, TMB, RNA expression profiles, immune cell subtypes, cytokines, metabolites, tumor and gut microbiota'}], 'primaryOutcomes': [{'measure': '1-year PFS', 'timeFrame': '12 months', 'description': 'Time between enrollment and recurrence of disease or death'}, {'measure': 'Incidence of Grade ≥3 Treatment-Related Adverse Events', 'timeFrame': 'Occurrence or end of follow-up（3 years after enrollment), which comes first', 'description': 'Safety'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'Occurrence or end of follow-up（3 years after enrollment）, which comes first', 'description': 'Time between enrollment and death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'carbon ion radiotherapy', 'immunotherapy'], 'conditions': ['Carbon Ion Radiotheray']}, 'descriptionModule': {'briefSummary': 'This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.', 'detailedDescription': 'All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system would receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with unresectable locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).\n* No prior anti-cancer treatment.\n* No significant internal medical conditions or major organ dysfunction.\n\nExclusion Criteria:\n\n* Histological evidence of small cell lung cancer or other primary malignancies\n* EGFR, ALK, or ROS-1 gene mutations.\n* Active or prior autoimmune/inflammatory disorders.\n* Inability to comply with study protocol as judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT07035860', 'briefTitle': 'Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'HZCIRT-Lung 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy', 'interventionNames': ['Radiation: Carbon ion radiotherapy', 'Drug: Chemotherapy', 'Drug: Immunotherapy']}], 'interventions': [{'name': 'Carbon ion radiotherapy', 'type': 'RADIATION', 'description': 'Patients will receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.', 'armGroupLabels': ['Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'platinum-based doublet chemotherapy', 'armGroupLabels': ['Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy']}, {'name': 'Immunotherapy', 'type': 'DRUG', 'description': 'The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.', 'armGroupLabels': ['Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Yongling Ji, MD', 'role': 'CONTACT', 'email': 'drjyl@msn.com', 'phone': '0086-571-88122088'}, {'name': 'Min Fang', 'role': 'CONTACT', 'email': '541387924@qq.com', 'phone': '0086-571-88122088'}, {'name': 'Yongling Ji, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yongling JI, MD', 'role': 'CONTACT', 'email': 'drjyl@msn.com', 'phone': '0086-571-88122088'}, {'name': 'Min Fang', 'role': 'CONTACT', 'email': '541387924@qq.com', 'phone': '0086-571-88122088'}], 'overallOfficials': [{'name': 'Yongling JI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ji Yongling', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Ji Yongling', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}