Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-01 @ 1:43 PM
Study NCT ID:
NCT04116918
Status:
UNKNOWN
Last Update Posted:
2019-10-07
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
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': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months', 'description': 'Time from treatment beginning until disease progression'}, {'measure': 'Objective Response Rate', 'timeFrame': 'Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months', 'description': 'Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months', 'description': 'Time from treatment beginning until death from any cause'}, {'measure': 'Adverse Effect', 'timeFrame': 'Through study completion, an average of 1 months', 'description': 'Incidence of Treatment-related adverse Events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC Stage IV', 'EGFR T790M-negative', 'Anlotinib', 'JS001']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.', 'detailedDescription': 'All EGFR mutation NSCLC patients with EGFR-TKIs eventually develop acquired resistance and in 40%-50% of these the resistance mechanism is based on the EGFR T790M mutation who could receive Osimertinib. Several alternative mechanisms of escape from EGFR-TKIs have been detected in NSCLC patients without the T790M, such as Met application, BRAF mutation, PIK3CA mutation, etc, who could receive the combination of EGFR-TKI with comparable target drug. Given the lack of targeted therapy for the majority of T790M-negative patients, platinum-doublet chemotherapy remains the standard of care with low effectiveness. In the present study, we aimed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'EGFR-TKI Resistant T790M-Negative NSCLC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>=18 years of age\n* Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation\n* EGFR-TKI resistent\n* EGFR T790M negative\n* Expected survival ≥ 3 month;\n* ECOG / PS score: 0-2;\n* the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \\<1.5 times the upper limit of normal (ULN); Liver ALT and AST \\<2.5 × ULN and if liver metastases, ALT and AST \\<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min\n\nExclusion Criteria:\n\n* EGFR-T790M positive\n* with druggable gene alteration;\n* Patient can not comply with research program requirements or follow-up;'}, 'identificationModule': {'nctId': 'NCT04116918', 'briefTitle': 'Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC', 'orgStudyIdInfo': {'id': 'AJERTNN'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-Dong Jiao, MD.PHD', 'role': 'CONTACT', 'email': 'pulava@139.com', 'phone': '+86-13817797639'}, {'name': 'Yuan-sheng Zang, MD.PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baodong Qin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Resident', 'investigatorFullName': 'Baodong Qin', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}