Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT02418234
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2015-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mashenglin@medmail.com.cn', 'phone': '086057156007664', 'title': 'Prof. Shenglin Ma', 'organization': "Hangzhou first people's hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TKI-PD', 'description': 'Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.', 'otherNumAtRisk': 314, 'otherNumAffected': 0, 'seriousNumAtRisk': 314, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TKI-PD'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 years', 'description': 'The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TKI-PD', 'description': 'Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '70.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.', 'unitOfMeasure': 'percentage of total ctDNA', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chest Limited', 'description': 'Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.'}, {'id': 'OG001', 'title': 'Brain Limited', 'description': 'Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.'}, {'id': 'OG002', 'title': 'Other Sites Failures', 'description': 'Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.'}], 'classes': [{'title': 'T790M positive by ARMS', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'T790M positive by ddPCR', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 years', 'description': 'The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chest Limited', 'description': 'Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.'}, {'id': 'OG001', 'title': 'Brain Limited', 'description': 'Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.'}, {'id': 'OG002', 'title': 'Other Sites Failures', 'description': 'Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '34.61'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.07'}, {'value': '0.56', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '70.3'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.', 'unitOfMeasure': 'percentage of total ctDNA', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TKI-PD', 'description': 'Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TKI-PD', 'description': 'Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '177', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '314', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stage', 'classes': [{'title': 'IIIA', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'IIIB', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '239', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Each patient was staged according to NCCN guidelines (2015. v6) at the time of enrollment. Generally, Stage IV showed worse prognosis.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2015-04-03', 'resultsFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-27', 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay', 'timeFrame': 'up to 2 years', 'description': 'The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).'}, {'measure': 'Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient', 'timeFrame': 'up to 2 years', 'description': 'The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.'}], 'secondaryOutcomes': [{'measure': 'Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure', 'timeFrame': 'up to 2 years', 'description': 'The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.'}, {'measure': 'Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure', 'timeFrame': 'up to 2 years', 'description': 'The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-small Cell Lung Cancer', 'circulating tumor DNA', 'T790M', 'amplification refractory mutation system', 'digital droplet PCR'], 'conditions': ['Non-small Cell Lung Cancer Stage III', 'Non-Small-Cell Lung Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.', 'detailedDescription': 'An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed stage IIIB/IV NSCLC.\n* Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment\n* Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months\n* Patient must be able to comply with the protocol\n\nExclusion Criteria:\n\n* Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.\n* Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.\n* Histologically confirmed small cell lung cancer or other metastatic tumors\n* Patient with no histologic or cytological diagnosis.'}, 'identificationModule': {'nctId': 'NCT02418234', 'briefTitle': 'T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study', 'orgStudyIdInfo': {'id': 'HZFH CA15-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mutation detection', 'type': 'OTHER'}, {'name': 'ARMS and ddPCR', 'type': 'OTHER'}, {'name': 'ctDNA analysis', 'type': 'GENETIC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}