Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03125603|
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : February 19, 2019
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|
|Carcinoma, Non-Small-Cell Lung Drug-Related Side Effects and Adverse Reactions||Other: Consultation of the patient's medical files at the hospital|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||80 participants|
|Target Follow-Up Duration:||20 Months|
|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 :||April 13, 2017|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
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).
- Census and monitor of the side-effects due to the immunotherapy treatment. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125603
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Study Director:||Thierry Pieters, MD, PhD||Cliniques universitaires Saint-Luc|