Carcinoma, Non-Small-Cell Lung, Drug-Related Side Effects and Adverse Reactions
Conditions
Keywords
Immunotherapy, Anti-PD-(L)-1, Anti-CTLA-4
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.
Interventions
OTHERConsultation of the patient's medical files at the hospital
Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Census and monitor of the side-effects due to the immunotherapy treatment. | Through study completion, an average of 20 months. | Census of the side-effect type, severity according to the CTCAE and monitoring the side-effect's development. |
Countries
Belgium
Outcome results
None listed