Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer

NCT03125603 | Completed

• 1 other identifier: 2017/15MAR/137
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The immune-related adverse events (irAEs) linked to the important activation of the immune system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma (NSCLC) have not received a lot of systematic study or been monitored over time outside of clinical trials. 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.

Conditions

Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions

Keywords

Immunotherapy; Anti-PD-(L)-1; Anti-CTLA-4

Outcome Measures

Primary Outcomes (1)

• Census and monitor of the side-effects due to the immunotherapy treatment.

  Census of the side-effect type, severity according to the CTCAE and monitoring the side-effect's development.

  Through study completion, an average of 20 months.

Study Arms (1)

NSCLC's patients

Patients with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy. Consultation of the patient's medical files at the hospital.

Other: Consultation of the patient's medical files at the hospital

Interventions

Consultation of the patient's medical files at the hospital OTHER

Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).

NSCLC's patients

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cliniques Universitaires Saint-Luc's patients with NSCLC eligible and treated with immunotherapy.

You may qualify if:

• Any patient with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy in first or second line.

You may not qualify if:

• The refusal to sign the consent.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (7)

• 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.

  PMID: 26412456 RESULT

• 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.

  PMID: 26028407 RESULT

• 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.

  PMID: 26765102 RESULT

• 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.

  PMID: 26629425 RESULT

• 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.

  PMID: 25605845 RESULT

• 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.

  PMID: 26715621 RESULT

• 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.

  PMID: 27718847 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Chemically-Induced Disorders

Study Officials

• Thierry Pieters, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Med student

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: April 13, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)