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CompletedNCT03125603Updated Feb 19, 2019

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

An observational study in Carcinoma, Non-Small-Cell Lung and Drug-Related Side Effects and Adverse Reactions, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
80
Ages
20 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • Drug-Related Side Effects and Adverse Reactions

Keywords

  • Immunotherapy
  • Anti-PD-(L)-1
  • Anti-CTLA-4
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 80 is below the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cliniques Universitaires Saint-Luc's patients with NSCLC eligible and treated with immunotherapy.

Inclusion criteria

  • Any patient with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy in first or second line.

Exclusion criteria

Exclusion Criteria:

  • The refusal to sign the consent.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
80 participants (actual)
Target follow-up
20 Months
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • OtherConsultation of the patient's medical files at the hospital

    Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).

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What researchers measure

Primary outcomes

  1. Census and monitor of the side-effects due to the immunotherapy treatment.

    Census of the side-effect type, severity according to the CTCAE and monitoring the side-effect's development.

    Time frame: Through study completion, an average of 20 months.

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Study locations

1 site
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
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References and documents

Publications

  • Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27. PubMed 26412456 ↗
  • Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31. PubMed 26028407 ↗
  • Michot JM, Bigenwald C, Champiat S, Collins M, Carbonnel F, Postel-Vinay S, Berdelou A, Varga A, Bahleda R, Hollebecque A, Massard C, Fuerea A, Ribrag V, Gazzah A, Armand JP, Amellal N, Angevin E, Noel N, Boutros C, Mateus C, Robert C, Soria JC, Marabelle A, Lambotte O. Immune-related adverse events with immune checkpoint blockade: a comprehensive review. Eur J Cancer. 2016 Feb;54:139-148. doi: 10.1016/j.ejca.2015.11.016. Epub 2016 Jan 5. PubMed 26765102 ↗
  • Villadolid J, Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Transl Lung Cancer Res. 2015 Oct;4(5):560-75. doi: 10.3978/j.issn.2218-6751.2015.06.06. PubMed 26629425 ↗
  • Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015 Jun 10;33(17):1974-82. doi: 10.1200/JCO.2014.59.4358. Epub 2015 Jan 20. PubMed 25605845 ↗
  • Champiat S, Lambotte O, Barreau E, Belkhir R, Berdelou A, Carbonnel F, Cauquil C, Chanson P, Collins M, Durrbach A, Ederhy S, Feuillet S, Francois H, Lazarovici J, Le Pavec J, De Martin E, Mateus C, Michot JM, Samuel D, Soria JC, Robert C, Eggermont A, Marabelle A. Management of immune checkpoint blockade dysimmune toxicities: a collaborative position paper. Ann Oncol. 2016 Apr;27(4):559-74. doi: 10.1093/annonc/mdv623. Epub 2015 Dec 28. PubMed 26715621 ↗
  • Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8. PubMed 27718847 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03125603
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Alexandre Niset (Med student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain) — Principal investigator
First posted
Apr 24, 2017
Start date
Apr 13, 2017
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018
Last update
Feb 19, 2019

Study contacts

Thierry Pieters, MD, PhD
study director · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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