Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT06771960
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between RVT and Prognosis After Neoadjuvant Targeted Therapy in EGFR NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Disease-free survival (DFS) was defined as the time from the date of surgery to the date of recurrence or last follow-up. Estimated final follow-up is 3 years postoperatively.', 'description': 'Disease-free survival (DFS) was defined as the time from the date of surgery to the date of recurrence or last follow-up.'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Event-free survival (EFS) was defined as the time from the date of diagnosis to the date of first event (relapse or death) or last follow-up. Estimated final follow-up is 3 years postoperatively.', 'description': 'Event-free survival (EFS) was defined as the time from the date of diagnosis to the date of first event (relapse or death) or last follow-up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'Neoadjuvant targeted therapy', 'residual viable tumor', 'prognosis', 'EGFR-Mutated'], 'conditions': ['Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'EGFR-mutated NSCLC is a distinct subtype that responds well to targeted therapies. Neoadjuvant targeted therapy aims to downstage tumors and improve surgical outcomes, but the prognostic role of residual viable tumor (RVT) remains unclear. This retrospective study examines the association between RVT and survival outcomes. The findings will further validate the importance of RVT as a surrogate.', 'detailedDescription': 'Non-small cell lung cancer (NSCLC) with EGFR mutations represents a molecularly distinct subset of lung cancer that benefits from targeted therapies. Neoadjuvant targeted therapy has emerged as a promising approach for locally advanced NSCLC, aiming to achieve tumor downstaging and improve surgical outcomes. However, the prognostic significance of residual viable tumor (RVT) after neoadjuvant targeted therapy remains poorly understood. This retrospective study investigates the association between the percentage of RVT and survival outcomes in EGFR-mutated NSCLC patients following neoadjuvant targeted therapy. Specific survival outcomes were disease-free survival (DFS) and event-free survival (EFS). By highlighting RVT as a critical prognostic biomarker, the findings provide actionable insights for optimizing postoperative management and stratifying high-risk patients. This work underscores the need for pathological evaluation of RVT to refine prognosis and treatment strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with EGFR-mutant NSCLC who received neoadjuvant targeted therapy followed by definitive surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years old;\n* Pathologically diagnosed EGFR-mutated non-small cell lung cancer (NSCLC);\n* Treated with neoadjuvant targeted therapy;\n* Undergoing definitive surgery.\n\nExclusion Criteria:\n\n* A history of prior chemotherapy, immunotherapy, or radiotherapy.\n* A history of malignancy or lung surgery;\n* Missing key data.'}, 'identificationModule': {'nctId': 'NCT06771960', 'briefTitle': 'Association Between RVT and Prognosis After Neoadjuvant Targeted Therapy in EGFR NSCLC', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Association Between Residual Viable Tumor and Prognosis After Neoadjuvant Targeted Therapy in EGFR-Mutated Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'RVT-LUNG'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guibin Qiao', 'role': 'CONTACT', 'email': 'guibinqiao@126.com', 'phone': '+86-13602749153'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Guibin Qiao', 'role': 'CONTACT', 'email': 'guibinqiao@126.com', 'phone': '+86-13602749153'}], 'overallOfficials': [{'name': 'Guibin Qiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'GuiBin Qiao', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}