Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer
NCT ID: NCT03125603
Last Updated: 2019-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2017-04-13
2018-08-01
Brief Summary
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This study aims to verify, on the basis of the data collected in a prospective and retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments observed in the target population of the controlled clinical trials are the same as in the general clinical population.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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NSCLC's patients
Patients with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy.
Consultation of the patient's medical files at the hospital.
Consultation of the patient's medical files at the hospital
Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).
Interventions
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Consultation of the patient's medical files at the hospital
Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
85 Years
ALL
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Alexandre Niset
Med student
Principal Investigators
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Thierry Pieters, MD, PhD
Role: STUDY_DIRECTOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Countries
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References
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Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.
Michot JM, Bigenwald C, Champiat S, Collins M, Carbonnel F, Postel-Vinay S, Berdelou A, Varga A, Bahleda R, Hollebecque A, Massard C, Fuerea A, Ribrag V, Gazzah A, Armand JP, Amellal N, Angevin E, Noel N, Boutros C, Mateus C, Robert C, Soria JC, Marabelle A, Lambotte O. Immune-related adverse events with immune checkpoint blockade: a comprehensive review. Eur J Cancer. 2016 Feb;54:139-148. doi: 10.1016/j.ejca.2015.11.016. Epub 2016 Jan 5.
Villadolid J, Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Transl Lung Cancer Res. 2015 Oct;4(5):560-75. doi: 10.3978/j.issn.2218-6751.2015.06.06.
Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015 Jun 10;33(17):1974-82. doi: 10.1200/JCO.2014.59.4358. Epub 2015 Jan 20.
Champiat S, Lambotte O, Barreau E, Belkhir R, Berdelou A, Carbonnel F, Cauquil C, Chanson P, Collins M, Durrbach A, Ederhy S, Feuillet S, Francois H, Lazarovici J, Le Pavec J, De Martin E, Mateus C, Michot JM, Samuel D, Soria JC, Robert C, Eggermont A, Marabelle A. Management of immune checkpoint blockade dysimmune toxicities: a collaborative position paper. Ann Oncol. 2016 Apr;27(4):559-74. doi: 10.1093/annonc/mdv623. Epub 2015 Dec 28.
Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.
Other Identifiers
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2017/15MAR/137
Identifier Type: -
Identifier Source: org_study_id
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