Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-13 @ 12:17 PM
Study NCT ID:
NCT03647592
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2018-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous 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': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue sample and plasma DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', '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': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Approximately 1 years', 'description': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'Approximately 1 years', 'description': 'Overall survival'}, {'measure': 'DCR', 'timeFrame': 'Approximately 1 years', 'description': 'Disease control rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small Cell Lung Cancer', 'Bevacizumab', 'Erlotinib/Gefitinib', 'EGFR mutation positive'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.', 'detailedDescription': 'A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T 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 tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 non-saquamous non-small cell lung cancer with EGFR mutation positive (19del/L858R) were inrolled in this study.\n\nECOG PS 0-1 All the patients recieved the treatment of erlotinib combined with Bevacizumab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EGFR mutation(19del/L858R)\n* advanced non-saquamous non-small cell lung cancer\n* primary treatment of first diagnosis\n* performance status（0-1)\n\nExclusion Criteria:\n\n* other genes mutation\n* saquamous'}, 'identificationModule': {'nctId': 'NCT03647592', 'briefTitle': 'Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'WECAN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohorts 1', 'description': 'patients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab', 'interventionNames': ['Drug: Erlotinib/Gefitinib combined with Bevacizumab']}], 'interventions': [{'name': 'Erlotinib/Gefitinib combined with Bevacizumab', 'type': 'DRUG', 'otherNames': ['treatment of A+T'], 'description': 'Erlotlnib,150mg po qd/gefitinib 250mg po qd +Bevacizumab(15mg/kg),lvgtt,every 21 day ,evaluate every 2 months', 'armGroupLabels': ['Cohorts 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+86 731 89762323'}, {'name': 'Chunhua Zhou, MD', 'role': 'CONTACT', 'email': 'zhouchunhua@hnszlyy.com', 'phone': '+86 731 89762321'}, {'name': 'Nong Yang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hunan Provincal Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongchang Z MD, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '7+861383123436'}, {'name': 'Yongchang Z MD, PhD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '+8613873123436'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}