Status:
SUSPENDED
Coorticosteroid Regimen in Patients With Anti-PD-1/PD-L1 Induced Pneumonitis
Lead Sponsor:
National Institute for Tuberculosis and Lung Diseases, Poland
Conditions:
Lung Neoplasm Malignant
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective interventional open-label randomized trial. The patients treated with anti- PD-1 (programmed-death receptor type 1) or anti-PD-L1 (programmed-death ligand) antibodies in case of...
Detailed Description
1\. Diagnostic period The screening for the study will involve patients with newly diagnosed interstitial changes in chest radiological examination or in patient with new respiratory system related sy...
Eligibility Criteria
Inclusion
- age over 18 years old
- histological or cytological confirmation of solid cancer
- treatment with anti-PD-1 or anti-PD-L1 antibody in monotherapy or in combination with cytotoxic chemotherapy or antiangiogenic agents like anti-vascular epitheliar growth factor antibodies
- acute onset respiratory symptoms or lung changes in radiologic examinations which were not present before immunotherapy was introduced e. signed informed consent
Exclusion
- concomitant or previous treatment with anti-CTLA4 or other immunotherapeutic agents
- active untreated tuberculosis
- the use of glucocorticosteroids in the dose equivalent to 10mg q 24h or more of prednisone in the last 4 weeks in indication other than pneumonitis or different immune related adverse event d. withdraw of consent
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04036721
Start Date
October 1 2019
End Date
February 1 2026
Last Update
February 23 2023
Active Locations (1)
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1
Instutut Gruzlicy I Chorob Pluc
Warsaw, Masovian Voivodeship, Poland, 01-138