Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 11:10 PM
Study NCT ID:
NCT06540950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-07
First Post:
2024-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-03', 'studyFirstSubmitDate': '2024-07-13', 'studyFirstSubmitQcDate': '2024-08-03', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'The time between the start of treatment and death from any cause in the one-arm trial'}, {'measure': 'objective response rate', 'timeFrame': '3 months', 'description': 'The ratio of complete response and partial response at 3 months after the end of radiotherapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vinorelbine']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.', 'detailedDescription': 'Patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥40 years old.\n2. Patients must have histologically or cytologically confirmed non-small cell lung cancer.\n3. ECOG PS was 0 or 1.\n4. Adequate organ and bone marrow function is present. Absolute neutrophil counts, platelet counts, and hemoglobin criteria must not be met after blood transfusion or growth factor support within 14 days prior to randomization.\n\nExclusion Criteria:\n\n1. History of allogeneic organ transplantation.\n2. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \\[Colitis or Crohn's disease\\], diverticulitis \\[other than diverticulitis\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \\[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis\\]).\n3. There is uncontrolled serious underlying diseases, including active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease.\n4. History of another primary malignancy.\n5. History of active primary immunodeficiency.\n6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.\n7. For any unmitigated toxicity during pre-study chemoradiotherapy. Patients who develop irreversible toxicity and are reasonably expected not to worsen after study treatment (such as hearing loss) may enter the study after consultation with the study physician.\n8. Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy.\n9. Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study."}, 'identificationModule': {'nctId': 'NCT06540950', 'briefTitle': 'Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Study of Oral Vinorelbine Single Drug Concurrent Chemoradiotherapy and Immune-maintenance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NCC3690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral vinorelbine concurrent radiotherapy group', 'description': 'All patients with unresectable stage III non-small cell lung cancer who received neoadjuvant chemo-immunotherapy received oral vinorelbine (60mg per square meter of body-surface area every 2 weeks before radiotherapy, and 30mg per square meter of body-surface area per week during radiotherapy) as radical concurrent chemoratherapy.', 'interventionNames': ['Drug: vinorelbine']}], 'interventions': [{'name': 'vinorelbine', 'type': 'DRUG', 'otherNames': ['oral vinorelbine concurrent chemoradiotherapy'], 'description': 'Vinorelbine is administered orally at 60mg per square meter per week by body surface area before radiotherapy and continued to be administered at 30mg per square meter per week during radiotherapy until the end of radiotherapy. Within 6 weeks after the end of radiotherapy, there are no serious side effects, and immune checkpoint inhibitors monotherapy can be performed.', 'armGroupLabels': ['Oral vinorelbine concurrent radiotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Lei Deng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}