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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Census and Follow-up of the Side Effects in the New Immunotherapeutic Treatments Anti-PD-(L)-1 and Anti-CTLA-4 of the Non Small Cells Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125603
• Other study ID #: 2017/15MAR/137
• Status: Completed
• Start date: April 13, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: February 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• The refusal to sign the consent.

Related Conditions & MeSH terms

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

Intervention

Other:
• Consultation of the patient's medical files at the hospital
Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & 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, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR Jr, — View Citation

Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbis — View Citation

Champiat S, Lambotte O, Barreau E, Belkhir R, Berdelou A, Carbonnel F, Cauquil C, Chanson P, Collins M, Durrbach A, Ederhy S, Feuillet S, François H, Lazarovici J, Le Pavec J, De Martin E, Mateus C, Michot JM, Samuel D, Soria JC, Robert C, Eggermont A, Ma — View Citation

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 — View Citation

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. Review. — View Citation

Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fülöp 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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.