Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-07 @ 9:27 PM
Study NCT ID:
NCT04122833
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2019-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of mutation profiles between pre/post TKI treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Comparison of the kinds of the mutation between pre- and post TKI treatment'}], 'secondaryOutcomes': [{'measure': 'PFS according to the co-occurring mutations with pre-TKI treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The investigators will compared the PFS according to the kinds of co-occuring genetic alteration in patient with EGFR -mutated adenocarcinoma before the EGFR TKI treatment'}, {'measure': 'The number and the kinds of co-occurring mutations on tumors before and after TKI treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The investigators will collect the information about the number and the kinds of co-occurring mutations on tumors before and after TKI treatment in Foundation medicine NGS'}, {'measure': 'The correlation between the change of variant allele frequency(VAF) and drug response in matched tumors tissues before and after TKI treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The investigators will analyze the correlation with the change of the VAF and PFS in matched tumors tissues before and after TKI treatment'}, {'measure': 'Tumor mutation burden in tumors tissues before and after TKI treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The investigators will compare the TMB in tumors tissues before and after TKI'}, {'measure': 'The concordance the the mutation profiles in the NGS results of tissue and blood in the same patients', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The investigators will compare the concordance of the mutation profile in tumors and blood before TKI treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['next generation sequencing'], 'conditions': ['Adenocarcinoma of Lung', 'EGFR Activating Mutation']}, 'referencesModule': {'references': [{'pmid': '23816960', 'type': 'BACKGROUND', 'citation': "Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1."}, {'pmid': '30391576', 'type': 'BACKGROUND', 'citation': 'Kim Y, Lee B, Shim JH, Lee SH, Park WY, Choi YL, Sun JM, Ahn JS, Ahn MJ, Park K. Concurrent Genetic Alterations Predict the Progression to Target Therapy in EGFR-Mutated Advanced NSCLC. J Thorac Oncol. 2019 Feb;14(2):193-202. doi: 10.1016/j.jtho.2018.10.150. Epub 2018 Nov 1.'}, {'pmid': '30045933', 'type': 'BACKGROUND', 'citation': 'Offin M, Rizvi H, Tenet M, Ni A, Sanchez-Vega F, Li BT, Drilon A, Kris MG, Rudin CM, Schultz N, Arcila ME, Ladanyi M, Riely GJ, Yu H, Hellmann MD. Tumor Mutation Burden and Efficacy of EGFR-Tyrosine Kinase Inhibitors in Patients with EGFR-Mutant Lung Cancers. Clin Cancer Res. 2019 Feb 1;25(3):1063-1069. doi: 10.1158/1078-0432.CCR-18-1102. Epub 2018 Jul 25.'}, {'pmid': '29530932', 'type': 'BACKGROUND', 'citation': 'Yu HA, Suzawa K, Jordan E, Zehir A, Ni A, Kim R, Kris MG, Hellmann MD, Li BT, Somwar R, Solit DB, Berger MF, Arcila M, Riely GJ, Ladanyi M. Concurrent Alterations in EGFR-Mutant Lung Cancers Associated with Resistance to EGFR Kinase Inhibitors and Characterization of MTOR as a Mediator of Resistance. Clin Cancer Res. 2018 Jul 1;24(13):3108-3118. doi: 10.1158/1078-0432.CCR-17-2961. Epub 2018 Mar 12.'}, {'pmid': '27821794', 'type': 'BACKGROUND', 'citation': 'Socinski MA, Villaruz LC, Ross J. Understanding Mechanisms of Resistance in the Epithelial Growth Factor Receptor in Non-Small Cell Lung Cancer and the Role of Biopsy at Progression. Oncologist. 2017 Jan;22(1):3-11. doi: 10.1634/theoncologist.2016-0285. Epub 2016 Nov 7.'}]}, 'descriptionModule': {'briefSummary': 'The concomitant co-mutation with epidermal growth factor receptor (EGFR) mutation might influence the clinical outcomes. The investigators will identify the impact of concommitant mutation on clinical outcome in patients with advanced -EGFR mutated adenocarcinoma.\n\nThe investigators will compare the genetic alterations between tumors of pre and post Tyrosin Kinase Inhibitor(TKI) treatments and predict the resistance mechanism for EGFR-TKIs by next-generation sequencing(NGS) analysis.', 'detailedDescription': "The current standard therapies in the treatment of advanced EGFR-mutated lung cancer patients are the 1st or 2nd EGFR-TKIs. Although 70-80% of patients treated by EGFR-TKIS show good responses, they have progression after around 12 months. The concomitant co-mutation with EGFR mutation might influence the drug response of EGFR TKI. The investigators will compare the progression-free survival (PFS) of EGFR-TKI according to co-occuring mutations.\n\nThe patients experience the change of molecular profiles after using the TKI. Therefore, the investigators will investigate the molecular profiles through NGS panel with foundation medicine in the tissue of pre/post EGFR-TKI, compare the change of the molecular profiles and tumor mutation burden(TMB), and identify novel mechanisms of drug resistance.\n\nThe investigators will collect the tumor tissues and blood of around 80 patients in multi-centers prospectively. Then, They will be sent to FoundationOne in the US and perform NGS analysis. The type of EGFR-TKIs would be selected according to physicians' preference. NGS will be performed twice before the EGFR-TKIs treatment and after the progression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'EGFR-mutated stage IV lung adenocarcinoma patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent Form\n2. Age ≥19 years\n3. EGFR-mutated stage IV lung adenocarcinoma patients\n4. Archival biopsy tissues which are from core needle biopsies, endobronchial ultrasound (EBUS) guided- lymph node biopsy or lymph node excisional biopsy at baseline and at radiologic progression\n5. Availability of the 10 unstained slides and 1 H\\&E slides at pre/ post TKI treatment\n6. Samples should contain a minimum of 20% viable tumor cells that preserve\n\nExclusion Criteria:\n\nTumor tissue from bone metastases that have been decalcified are not acceptable.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04122833', 'briefTitle': 'Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'A Next-generation Sequencing Analysis to Investigate the Clinical Impact of Concomitant Genetic Alterations in the Patients With Advanced EGFR-mutated Lung Adenocarcinoma: A Multicenter Study.', 'orgStudyIdInfo': {'id': 'ML41560'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Next generation sequencing', 'type': 'OTHER', 'description': 'observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Chul Lee, Ph.D', 'role': 'CONTACT'}], 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Joon Kim, MD.Ph.D.', 'role': 'CONTACT'}], 'facility': "Catholic university medical center, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'In Ae Kim, MD. Ph.D', 'role': 'CONTACT', 'email': '20180618@kuh.ac.kr', 'phone': '01035438353'}, {'name': 'Kye Young Lee, MD. Ph.D', 'role': 'CONTACT', 'email': 'kykeemd@kuh.ac.kr', 'phone': '01088963916'}], 'overallOfficials': [{'name': 'In Ae Kim, MD. Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kunkuk University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Diagnostics GmbH', 'class': 'INDUSTRY'}, {'name': 'Foundation Medicine', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kye Young Lee', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}