Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 6:40 PM
Study NCT ID:
NCT03513666
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2018-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '12 weeks', 'description': 'The primary endpoint is the antitumor activities in this study'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '18 months', 'description': 'Progression free survival (PFS)'}, {'measure': 'OS', 'timeFrame': '18 months', 'description': 'Overall survival (OS)'}, {'measure': 'DOR', 'timeFrame': '18 months', 'description': 'Duration of response (DOR)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'referencesModule': {'references': [{'pmid': '37388902', 'type': 'DERIVED', 'citation': 'Li LC, Chen XW, Fang L, Jian CL, Yu YX, Liao XY, Sun JG. YAP1 as a Novel Negative Biomarker of Immune Checkpoint Inhibitors for EGFR-Mutant Non-Small-Cell Lung Cancer. Can Respir J. 2023 Jun 21;2023:4689004. doi: 10.1155/2023/4689004. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOnly the patients meeting all the following criteria can be eligible to participate in the trial:\n\n* Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:\n* Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;\n* No exon 20 T790M mutation after failure of EGFR-TKI therapy;\n* At least one measurable lesion (in accordance with RECIST 1.1);\n\nExclusion Criteria:\n\nPatients who fulfill any of the following criteria must be excluded from the study:\n\n* Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component \\>10%;\n* Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;\n* Previous systemic chemotherapy for advanced NSCLC;\n* EGFR-TKI therapy within two weeks prior to enrollment;'}, 'identificationModule': {'nctId': 'NCT03513666', 'acronym': 'JS001', 'briefTitle': 'A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment：a Multi-center, Single Arm Phase II Study', 'orgStudyIdInfo': {'id': 'JS001-PII-LC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': 'Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy', 'interventionNames': ['Combination Product: Drug intervention']}], 'interventions': [{'name': 'Drug intervention', 'type': 'COMBINATION_PRODUCT', 'description': 'anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospita', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Medical School of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhengjiang', 'country': 'China', 'facility': 'Zhengjiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}