Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 1:41 PM
Study NCT ID:
NCT02226757
Status:
UNKNOWN
Last Update Posted:
2014-08-27
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-25', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': '6 weeks'}, {'measure': 'progression-free survival', 'timeFrame': '2 years'}, {'measure': 'Toxicity', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC', 'HER2-expression', 'EGFR-mutation', 'Trastuzumab', 'Paclitaxel'], 'conditions': ['NSCLC', 'HER2-expression', 'EGFR-mutation']}, 'descriptionModule': {'briefSummary': 'This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent.\n\nPatients will be treated with weekly paclitaxel-trastuzumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed stage IV non-squamous NSCLC patients.\n* Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).\n* Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.\n* There must be at least one measurable disease site, according to RECIST 1.1 criteria.\n* WHO performance status 0-2.\n* Willing and able to comply with the study prescriptions.\n* 18 years or older.\n* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.\n* Ability to give written informed consent before patient registration.\n\nExclusion Criteria:\n\n* No uncontrolled infectious disease.\n* No other active malignancy.\n* No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.\n* No treatment with investigational drugs.\n* No known hypersensitivity to trastuzumab-paclitaxel\n* No symptomatic brain metastases.\n* History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection Fraction (LVEF) of \\<45%.'}, 'identificationModule': {'nctId': 'NCT02226757', 'briefTitle': 'Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients After Progression on TKI-treatment; a Pilot-study', 'orgStudyIdInfo': {'id': 'HER2-targeting in EGFR-mutated'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel-trastuzumab', 'description': 'Paclitaxel-trastuzumab weekly', 'interventionNames': ['Drug: Paclitaxel-trastzumab']}], 'interventions': [{'name': 'Paclitaxel-trastzumab', 'type': 'DRUG', 'description': 'Trastuzumab\n\n* Dose:\n\n * First dose: 4 mg/kg IV\n * Subsequent doses: 2 mg/kg every week IV.\n* The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions.\n\nPaclitaxel\n\n\\- Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab', 'armGroupLabels': ['Paclitaxel-trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1007MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'contacts': [{'name': 'Justine Kuiper, MD', 'role': 'CONTACT', 'email': 'jl.kuiper@vumc.nl', 'phone': '+31204442214'}], 'facility': 'VU University medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Justine Kuiper, MD', 'role': 'CONTACT', 'email': 'jl.kuiper@vumc.nl', 'phone': '0031204442214'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Prof. dr. E.F. Smit', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}