Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06317558
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], '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'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-29', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR)', 'timeFrame': 'Within 15 days after surgery', 'description': 'defined as 0% of viable tumor cells in primary tumor and lymph nodes'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': 'DFS was defined as the time from surgery to the date of disease recurrence or death (by any cause in the absence of recurrence), up to about 10 years.', 'description': 'Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From date of surgery until date of death due to any cause, up to approximately 10 years.', 'description': 'OS is defined as the time from surgery time until death from any cause.'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.', 'description': 'EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.'}, {'measure': 'Major Pathological Response (MPR)', 'timeFrame': 'Within 15 days after surgery', 'description': 'defined as ≤10% of viable tumor cells'}, {'measure': 'Relapse Patterns', 'timeFrame': 'Within 10 years after surgery', 'description': 'Relapse was defined as disease recurrence at any site.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:\n\n* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?\n* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.', 'detailedDescription': 'The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:\n\n* What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy?\n* How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NSCLC patients receiving neoadjuvant immunotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)\n2. Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;\n3. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;\n4. Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;\n5. At least one measurable lesion (RECIST v1.1).\n\nExclusion Criteria:\n\n1. Patients included in unblinded clinical trials or anti-tumor drug intervention.\n2. Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.'}, 'identificationModule': {'nctId': 'NCT06317558', 'acronym': 'NeoIM-Lung', 'briefTitle': 'Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Real-world Clinical Outcomes of Neoadjuvant Immunotherapy in NSCLC Patients: A Retrospective, Multi-center, Cohort Study (NeoIM-Lung)', 'orgStudyIdInfo': {'id': '22/492-3694'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neoadjuvant immunotherapy', 'description': 'Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.', 'interventionNames': ['Drug: Neoadjuvant immunotherapy']}, {'label': 'Other neoadjuvant treatment', 'description': 'Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.', 'interventionNames': ['Drug: Other drugs for neoadjuvant treatment']}], 'interventions': [{'name': 'Neoadjuvant immunotherapy', 'type': 'DRUG', 'otherNames': ['Immune checkpoint inhibitors'], 'description': 'Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.', 'armGroupLabels': ['Neoadjuvant immunotherapy']}, {'name': 'Other drugs for neoadjuvant treatment', 'type': 'DRUG', 'otherNames': ['Other drugs'], 'description': 'Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.', 'armGroupLabels': ['Other neoadjuvant treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shugeng Gao, MD', 'role': 'CONTACT', 'email': 'gaoshugeng@cicams.ac.cn', 'phone': '010-87788177'}], 'facility': 'Shugeng Gao', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shugeng Gao, MD', 'role': 'CONTACT', 'email': 'gaoshugeng@cicams.ac.cn', 'phone': '8610-87788177'}], 'overallOfficials': [{'name': 'Shugeng Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}