Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 3:52 PM
Study NCT ID:
NCT04722406
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2021-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival of patients undergoing ICI monotherapy', 'timeFrame': 'From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.', 'description': 'Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival of patients undergoing ICI monotherapy.', 'timeFrame': 'From date of ICI treatment initiation until the date of first documented progression or date of death from any causes, whichever came first, assessed up to 100 months.', 'description': 'Progression-free survival was calculated from ICI initiation to radiologically-defined progression or death from any causes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tumor Growth Rate', 'NSCLC', 'immunotherapy'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '31422028', 'type': 'BACKGROUND', 'citation': 'Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeno J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crino L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. Lancet Oncol. 2019 Oct;20(10):1395-1408. doi: 10.1016/S1470-2045(19)30407-3. Epub 2019 Aug 14.'}, {'pmid': '30819829', 'type': 'BACKGROUND', 'citation': 'Xia L, Liu Y, Wang Y. PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions. Oncologist. 2019 Feb;24(Suppl 1):S31-S41. doi: 10.1634/theoncologist.2019-IO-S1-s05.'}, {'pmid': '30955977', 'type': 'BACKGROUND', 'citation': 'Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.'}, {'pmid': '29570421', 'type': 'BACKGROUND', 'citation': 'Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. J Clin Oncol. 2018 Jun 10;36(17):1675-1684. doi: 10.1200/JCO.2017.77.0412. Epub 2018 Mar 23.'}, {'pmid': '24240109', 'type': 'BACKGROUND', 'citation': 'Ferte C, Fernandez M, Hollebecque A, Koscielny S, Levy A, Massard C, Balheda R, Bot B, Gomez-Roca C, Dromain C, Ammari S, Soria JC. Tumor growth rate is an early indicator of antitumor drug activity in phase I clinical trials. Clin Cancer Res. 2014 Jan 1;20(1):246-52. doi: 10.1158/1078-0432.CCR-13-2098. Epub 2013 Nov 15.'}, {'pmid': '30910869', 'type': 'BACKGROUND', 'citation': "Lamarca A, Crona J, Ronot M, Opalinska M, Lopez Lopez C, Pezzutti D, Najran P, Carvhalo L, Franca Bezerra RO, Borg P, Vietti Violi N, Vidal Trueba H, de Mestier L, Schaefer N, Sundin A, Costa F, Pavel M, Dromain C; Knowledge Network. Value of Tumor Growth Rate (TGR) as an Early Biomarker Predictor of Patients' Outcome in Neuroendocrine Tumors (NET)-The GREPONET Study. Oncologist. 2019 Nov;24(11):e1082-e1090. doi: 10.1634/theoncologist.2018-0672. Epub 2019 Mar 25."}, {'pmid': '22344231', 'type': 'BACKGROUND', 'citation': 'Stein WD, Wilkerson J, Kim ST, Huang X, Motzer RJ, Fojo AT, Bates SE. Analyzing the pivotal trial that compared sunitinib and IFN-alpha in renal cell carcinoma, using a method that assesses tumor regression and growth. Clin Cancer Res. 2012 Apr 15;18(8):2374-81. doi: 10.1158/1078-0432.CCR-11-2275. Epub 2012 Feb 17.'}, {'pmid': '21763126', 'type': 'BACKGROUND', 'citation': 'Gomez-Roca C, Koscielny S, Ribrag V, Dromain C, Marzouk I, Bidault F, Bahleda R, Ferte C, Massard C, Soria JC. Tumour growth rates and RECIST criteria in early drug development. Eur J Cancer. 2011 Nov;47(17):2512-6. doi: 10.1016/j.ejca.2011.06.012. Epub 2011 Jul 15.'}, {'pmid': '15534099', 'type': 'BACKGROUND', 'citation': 'Camp RL, Dolled-Filhart M, Rimm DL. X-tile: a new bio-informatics tool for biomarker assessment and outcome-based cut-point optimization. Clin Cancer Res. 2004 Nov 1;10(21):7252-9. doi: 10.1158/1078-0432.CCR-04-0713.'}, {'pmid': '36442353', 'type': 'DERIVED', 'citation': 'He LN, Fu S, Ma H, Chen C, Zhang X, Li H, Du W, Chen T, Jiang Y, Wang Y, Wang Y, Zhou Y, Lin Z, Yang Y, Huang Y, Zhao H, Fang W, Zhang H, Zhang L, Hong S. Early on-treatment tumor growth rate (EOT-TGR) determines treatment outcomes of advanced non-small-cell lung cancer patients treated with programmed cell death protein 1 axis inhibitor. ESMO Open. 2022 Dec;7(6):100630. doi: 10.1016/j.esmoop.2022.100630. Epub 2022 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.', 'detailedDescription': "Tumor growth rate (TGR) signifies percentage change in tumor size per month (%/m). Electronic medical records were retrospectively reviewed for all histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.\n\nAll response and outcome evaluation were determined as per RECIST 1.1 by two senior radiologists blinded to patients'information. Discrepancy was solved by consensus.\n\nX-tile software was used to determine cut-off values that maximumly differentiate overall survival (OS). Log-rank tests and Cox regression models were performed for survival analysis. The predictive value of TGR for clinical outcomes in ICI-treated aNSCLC patients was validated in two external cohorts, recruited form Guangdong Province Traditional Chinese Medical Hospital and Shanghai Chest Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy (N = 172) at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed aNSCLC patients\n* Having received anti-PD-1/PD-L1 therapy\n* Must have two consecutive computed tomography (CT) scans upon early treatment (from baseline to the first imaging evaluation)\n\nExclusion Criteria:\n\n* Lacking available computed tomography (CT) evaluation at any of two time points-baseline and the first evaluation\n* Without measurable lesions at baseline CT scan\n* Having received local anticancer therapy during ICI treatment, for example, radiotherapy and radiofrequency ablation'}, 'identificationModule': {'nctId': 'NCT04722406', 'briefTitle': 'Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Tumor Growth Rate (TGR) as an Early Predictor of Clinical Outcomes in Advanced Non-small Cell Lung Cancer Treated With PD-1 Axis Inhibitors.', 'orgStudyIdInfo': {'id': 'SHong'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low TGR group', 'description': 'Patients with low level of TGR determined by X-tile program', 'interventionNames': ['Other: This item is not applicable to our observational study.']}, {'label': 'High TGR group', 'description': 'Patients with high level of TGR determined by X-tile program', 'interventionNames': ['Other: This item is not applicable to our observational study.']}], 'interventions': [{'name': 'This item is not applicable to our observational study.', 'type': 'OTHER', 'description': 'This item is not applicable to our observational study.', 'armGroupLabels': ['High TGR group', 'Low TGR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaodong Hong, MD', 'role': 'CONTACT', 'email': 'hongshd@sysucc.org.cn', 'phone': '+8615920527656'}, {'name': 'Shaodong Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haibo Zhang, MD', 'role': 'CONTACT', 'email': 'haibozh@gzucm.edu.cn', 'phone': '+8613724123615'}], 'facility': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaomin Niu, MD, PhD', 'role': 'CONTACT', 'email': 'ar_tey@hotmail.com', 'phone': '+8613917040510'}], 'facility': 'Shaihai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shaodong Hong, MD', 'role': 'CONTACT', 'email': 'hongshd@sysucc.org.cn', 'phone': '+8615920527656'}], 'overallOfficials': [{'name': 'Shaodong Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'The IPD and any additional supporting information will become available 3 months after publication.', 'ipdSharing': 'YES', 'description': 'Data including demographic characteristics, clinical information, radiological and follow-up information will be shared.', 'accessCriteria': 'data can be obtained from the principal investigator by e-mail upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician, MD', 'investigatorFullName': 'Shaodong Hong', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}