Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:55 PM
Study NCT ID:
NCT07166003
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Neoadjuvant Immunotherapy in Patients With 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': 'D011013', 'term': 'Pneumonectomy'}, {'id': 'D038481', 'term': 'Anterior Temporal Lobectomy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.'}, {'measure': 'Perioperative Complication rate', 'timeFrame': 'Within 6 months after neoadjuvant treatment.', 'description': 'Complications after the neoadjuvant treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer, Non-Small Cell', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are:\n\n* Does pneumonectomy bring more benefits for pateints than lobectomy?\n* Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.', 'detailedDescription': 'This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of neoadjuvant treatment in patients with lung cancer. Central to this investigation are two key questions: ·Does pneumonectomy bring more benefits for pateints than lobectomy?\n\n* Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment, and through rigorous analysis of data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lung cancer who receive neoadjuvant immunotherapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 18 and 79 years;\n2. Received at least two cycles of neoadjuvant immunotherapy;\n3. ECOG performance status score of 0;\n4. Complete clinical information including imaging data available.\n\nExclusion Criteria:\n\n1. Diagnosed with or suspected active autoimmune diseases;\n2. Presence of EGFR/ALK sensitive mutations;\n3. Pregnant or breastfeeding women;\n4. Previous anti-tumor therapies including chemotherapy or radiotherapy;\n5. History of organ transplantation or hematopoietic stem cell transplantation;\n6. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;\n7. Uncontrolled diabetes mellitus;\n8. Uncontrolled hypertension.'}, 'identificationModule': {'nctId': 'NCT07166003', 'acronym': 'NeoIP-Lung', 'briefTitle': 'Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study', 'orgStudyIdInfo': {'id': '2025040620521402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery', 'description': 'Patients will undergo surgery after neoadjuvant immunotherapy.', 'interventionNames': ['Procedure: Pneumonectomy', 'Procedure: lobectomy']}, {'label': 'Non-surgery', 'description': 'Patients will receive non-surgical treatment after neoadjuvant treatment.', 'interventionNames': ['Radiation: radiotherapy', 'Drug: Anti-Tumor Drugs']}], 'interventions': [{'name': 'Pneumonectomy', 'type': 'PROCEDURE', 'description': 'Patients will receive pneumonectomy after neoadjuvant treatment', 'armGroupLabels': ['Surgery']}, {'name': 'lobectomy', 'type': 'PROCEDURE', 'description': 'Patients will receive lobectomy after neoadjuvant immunotherapy.', 'armGroupLabels': ['Surgery']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'Patients will receive radiotherapy after neoadjuvant immunotherapy.', 'armGroupLabels': ['Non-surgery']}, {'name': 'Anti-Tumor Drugs', 'type': 'DRUG', 'description': 'Patients will receive anti-tumor drugs.', 'armGroupLabels': ['Non-surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shugeng Gao, MD', 'role': 'CONTACT', 'email': 'guowei@cicams.ac.cn', 'phone': '8610-87788177'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shugeng Gao, MD', 'role': 'CONTACT', 'email': 'gaoshugeng@cicams.ac.cn', 'phone': '8610-87788177'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}