Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02458651
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1378}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic and Socio-Behavioral Characteristics', 'timeFrame': 'At enrollment'}, {'measure': 'Medical History Characteristics', 'timeFrame': 'At enrollment'}, {'measure': 'Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile', 'timeFrame': 'At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years'}, {'measure': 'Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status', 'timeFrame': 'At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years'}, {'measure': 'Treatment Patterns of First-Line and Subsequent Treatments', 'timeFrame': 'At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From enrollment to end of study up to 1.5 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From enrollment to end of study up to 1.5 years'}], 'secondaryOutcomes': [{'measure': 'Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage', 'timeFrame': 'At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years'}, {'measure': 'Percentage of Serious Adverse Events (SAEs)', 'timeFrame': 'From enrollment to end of study up to 1.5 years'}, {'measure': 'Percentage of Adverse Events (AEs)', 'timeFrame': 'From enrollment to end of study up to 1.5 years'}, {'measure': 'Percentage of Non-Serious AEs of Special Interest (AESIs)', 'timeFrame': 'From enrollment to end of study up to 1.5 years'}]}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer, Lung Cancer, Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to describe patient and disease characteristics as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for various populations of patients defined by clinical and tumor characteristics, treatment patterns, and hospital category defined by city tier and geographic region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with newly diagnosed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/cytologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)\n* Received at least one anti-cancer treatment targeting unresectable Stage IIIB or IV NSCLC in the study site after study initiation\n* Radiographic evidence of disease\n\nExclusion Criteria:\n\n* Prior systematic treatment for unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)\n* Participation in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB or IV NSCLC.'}, 'identificationModule': {'nctId': 'NCT02458651', 'briefTitle': 'Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China', 'orgStudyIdInfo': {'id': 'YO29443'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tier 1 and North', 'description': 'Site as described by tier level of the city where the site is located and by geographical location: Tier 1 city in northern region of China', 'interventionNames': ['Other: No intervention']}, {'label': 'Tier 1 and South', 'description': 'Site as described by tier level of the city where the site is located and by geographical location: Tier 1 city in southern region of China', 'interventionNames': ['Other: No intervention']}, {'label': 'Tier 2 and Middle', 'description': 'Site as described by tier level of the city where the site is located and by geographical location: Tier city in middle region of China', 'interventionNames': ['Other: No intervention']}, {'label': 'Tier 2 and North', 'description': 'Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in northern region of China', 'interventionNames': ['Other: No intervention']}, {'label': 'Tier 2 and South Eastern', 'description': 'Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south eastern region of China', 'interventionNames': ['Other: No intervention']}, {'label': 'Tier 2 and South Western', 'description': 'Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south western region of China', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention administered in this study', 'armGroupLabels': ['Tier 1 and North', 'Tier 1 and South', 'Tier 2 and Middle', 'Tier 2 and North', 'Tier 2 and South Eastern', 'Tier 2 and South Western']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130021', 'city': 'Changchun', 'country': 'China', 'facility': 'the First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'Sichuan Provincial Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '400042', 'city': 'Chongqing', 'country': 'China', 'facility': 'Third Affiliated Hospital of Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350014', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '150081', 'city': 'Harbin', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '530021', 'city': 'Nanning', 'country': 'China', 'facility': 'The First Affiliate Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '430023', 'city': 'Wuhan', 'country': 'China', 'facility': 'Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': "First Affiliated Hospital of Medical College of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}