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

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT03125603
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 15.6
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions	Other: Consultation of the patient's medical files at the hospital

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Study Start Date: Apr 13, 2017
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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; Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

• Study Director: Thierry Pieters, MD, PhD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandre Niset, Med student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT03125603
• Other Study ID Numbers: 2017/15MAR/137
• First Posted: Apr 24, 2017
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alexandre Niset, Med student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain: Immunotherapy; Anti-PD-(L)-1; Anti-CTLA-4
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions

Study Results

No Results Posted as of Feb 19, 2019