Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-20 @ 11:07 AM
Study NCT ID:
NCT02886195
Status:
UNKNOWN
Last Update Posted:
2016-09-01
First Post:
2016-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-27', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-27', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Response Rate (RR)', 'timeFrame': '2 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '6 months'}, {'measure': 'Adverse Event (AE)', 'timeFrame': '2 months', 'description': 'NCI CTC 4.03'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['EGFR Gene Mutation']}, 'referencesModule': {'references': [{'pmid': '34168480', 'type': 'DERIVED', 'citation': 'Lin J, Li M, Chen S, Weng L, He Z. Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naive Advanced Non-Small-Cell Lung Cancer Patients Harboring Sensitive EGFR Mutations: A Single-Center, Open-Label, Single-Arm, Phase II Clinical Trial. J Inflamm Res. 2021 Jun 16;14:2557-2567. doi: 10.2147/JIR.S313056. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).', 'detailedDescription': 'This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).\n\nSubjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.\n\nThe endpoint of this study included clinical efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage Ⅳ EGFR mutation-positive NSCLC\n* Initial therapy\n* ECOG performance status 0-1\n\nExclusion Criteria:\n\n* EGFR mutation-negative\n* Previous systemic antitumour treatment'}, 'identificationModule': {'nctId': 'NCT02886195', 'acronym': 'effect', 'briefTitle': 'EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC', 'orgStudyIdInfo': {'id': 'secgolc001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PC plus erlotinib', 'description': 'pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy', 'interventionNames': ['Drug: pemetrexed', 'Drug: cisplatin', 'Drug: Erlotinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'erlotinib', 'description': 'erlotinib 150mg/d until "progress disease"', 'interventionNames': ['Drug: Erlotinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PC', 'description': 'pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles', 'interventionNames': ['Drug: pemetrexed', 'Drug: cisplatin']}], 'interventions': [{'name': 'pemetrexed', 'type': 'DRUG', 'description': '500mg/m2 ivgtt d1, per three weeks', 'armGroupLabels': ['PC', 'PC plus erlotinib']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '80mg/m2 ivgtt d1, per three weeks', 'armGroupLabels': ['PC', 'PC plus erlotinib']}, {'name': 'Erlotinib', 'type': 'DRUG', 'description': '150mg po. every day', 'armGroupLabels': ['PC plus erlotinib', 'erlotinib']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'zhiyong he he, master', 'role': 'STUDY_CHAIR', 'affiliation': 'Fujian province cancer hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Depending on the process of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}