NCT03125603

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Consultation of the patient's medical files at the hospital	Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).

Timeline

• Start date: 2017-04-13
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-04-24
• Last updated: 2019-02-19

Locations

1 site across 1 country: Belgium