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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions
• Interventions: Other: Consultation of the patient's medical files at the hospital

• Registration Number: NCT03125603
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-13
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-17
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium