Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-03 @ 4:34 AM
Study NCT ID:
NCT03755102
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2018-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'C525726', 'term': 'dacomitinib'}, {'id': 'C000596361', 'term': 'osimertinib'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': '1 year', 'description': 'Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EGFR C797S', 'EGFR mutant lung cancer', 'dacomitinib', 'osimertinib', '18-341', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['EGFR Gene Mutation', 'Lung Cancer', 'Lung Cancer Metastatic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Advanced biopsy-proven metastatic non-small cell lung cancer\n* Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy\n* Prior treatment with osimertinib with response followed by disease progression\n* No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)\n* Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation\n* Measurable (RECIST 1.1) indicator lesion not previously irradiated\n* Karnofsky performance status (KPS) \\>/= 70%\n* Age \\>/= 18 years old\n* Ability to swallow oral medication\n* Adequate organ function\n\n * AST, ALT \\</= 3 x ULN\n * Total bilirubin \\</= 1.5x ULN\n * Creatinine \\</= 1.5x ULN OR calculated creatinine clearance \\>/= 60ml/min\n * Absolute neutrophil count (ANC) \\>/= 1000 cells/mm3\n * Hemoglobin\\>/=8.0 g/dL\n * Platelets \\>/=75,000/mm3\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Any radiotherapy within 1 week of starting treatment on protocol.\n* Any major surgery within 1 weeks of starting treatment on protocol.\n* Any evidence of active clinically significant interstitial lung disease\n* Continue to have unresolved \\> grade 1 toxicity from any previous treatment Treatment\n* Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).\n* Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids'}, 'identificationModule': {'nctId': 'NCT03755102', 'briefTitle': 'A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.', 'orgStudyIdInfo': {'id': '18-341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Participants treated with dacomitinib alone', 'description': 'Participants in this cohort have a somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy.', 'interventionNames': ['Drug: Dacomitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Participants treated with dacomitinib in combination with osimertinib', 'description': 'Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation', 'interventionNames': ['Drug: Dacomitinib', 'Drug: Osimertinib']}], 'interventions': [{'name': 'Dacomitinib', 'type': 'DRUG', 'description': 'Cohort 1 Dacomitinib Dosing:\n\nDose level 1: Dacomitinib 45mg daily Dose level -1: Dacomitinib 30mg daily Dose level -2: Dacomitinib 15mg daily\n\nCohort 2 Dacomitinib Dosing:\n\nDose level 1: Dacomitinib 30 mg daily Dose level -1: Dacomitinib 15 mg daily', 'armGroupLabels': ['Cohort 1: Participants treated with dacomitinib alone', 'Cohort 2: Participants treated with dacomitinib in combination with osimertinib']}, {'name': 'Osimertinib', 'type': 'DRUG', 'description': 'In cohort 2, participants will begin on dacomitinib orally daily in combination with Osimertinib\n\nDose level Osimertinib Dosing:\n\nDose level 1: Osimertinib 80 mg daily Dose level -1: Osimertinib 40 mg daily', 'armGroupLabels': ['Cohort 2: Participants treated with dacomitinib in combination with osimertinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Rockville Centre', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'overallOfficials': [{'name': 'Helen Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}