Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 10:11 PM
Study NCT ID:
NCT03646994
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous 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': 'D000077547', 'term': 'Crizotinib'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue sample and plasma DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-25', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'may 2018- may 2019 (1 year)', 'description': 'progression survival time'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'may 2018- may 2019 (1 year)', 'description': 'objective response rate'}, {'measure': 'OS', 'timeFrame': 'may 2018- may 2019 (1 year)', 'description': 'over survival time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small Cell Lung Cancer', 'Crizotinib', 'ROS1 Rearranged'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '34511132', 'type': 'DERIVED', 'citation': 'Zhang Y, Zhang X, Zhang R, Xu Q, Yang H, Lizaso A, Xu C, Liu J, Wang W, Ou SI, Zhang J, Song Z, Yang N. Clinical and molecular factors that impact the efficacy of first-line crizotinib in ROS1-rearranged non-small-cell lung cancer: a large multicenter retrospective study. BMC Med. 2021 Sep 13;19(1):206. doi: 10.1186/s12916-021-02082-6.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to explore the efficacy and safety of Crizotinib as a first-line treatment for advanced NSCLC with ROS1 rearrangement positive mutation in the real world, explore the new drug resistance mechanism of ROS1 under Crizotinib treatment and the consistency of plasma and tissue detection driving genes, and finally evaluate the mutation spectrum of plasma dynamic detection driving genes. In predicting the risk of disease progression.', 'detailedDescription': 'This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced non-squamous non-small cell lung cancer (NSCLC) using Crizotinib ROS1 rearrangement positive mutation was conducted to observe the efficacy and safety of Crizotinib regimen in the real world.Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between NGS and plasma gene test (NGS) at the progression of clozotinib treatment; 3. Drug resistance mechanism of clozotinib in ROS1 rearrangement positive NSCLC; 4. Plasma drug resistance. Large panel dynamic driven gene mutation analysis was used to construct disease progression risk model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ROS1 rearranged Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology\n* ROS1 Arranged Positive\n* ROS1 Arranged Detection Method is NGS\n* First Diagnosis and Treatment\n* Treatment Plan is Kazolinib 250mg po bid\n\nExclusion Criteria:\n\n* Patients received antitumor treatment before\n* Patients with contraindication of chemotherapy\n* Pregnant or breast feeding women'}, 'identificationModule': {'nctId': 'NCT03646994', 'briefTitle': 'Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged Non-squamous Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CORE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohorts 1', 'description': 'ROS1 fusion positive NSCLC patients who received crizotinib', 'interventionNames': ['Drug: Crizotinib']}], 'interventions': [{'name': 'Crizotinib', 'type': 'DRUG', 'description': 'Crizotinib Cap 250 mg po bid', 'armGroupLabels': ['Cohorts 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+86 731 89762323'}, {'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+86 731 89762321'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '7+861383123436'}, {'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+8613873123436', 'phoneExt': '+8613873123436'}], 'overallOfficials': [{'name': 'Yongchang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}