NIPH Clinical Trials Search

JRCT ID: jRCTs031210327

Registered date:21/09/2021

Clinical trial of prednisolone for immune related interstitial lung disease

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedlung cancer, malignant mesothelioma
Date of first enrollment20/01/2022
Target sample size22
Countries of recruitment
Study typeInterventional
Intervention(s)CTCAE v5.0 grade 2 pneumonitis Patients will receive oral or intravenous prednisolone (1mg/kg/day) for 14 days. CTCAE v5.0 grade 3 pneumonitis Patients will receive intravenous prednisolone (2mg/kg/day) for 14 days.


Primary OutcomePercentage of cases in which CTCAE v5.0 pneumonitis grade on day 14 of prednisolone treatment improved by more than one levels from the time of regstration.
Secondary OutcomeCTCAE v5.0 pneumonitis grade at the end of prednisolone therapy. Toxicity Overall survival from the start of immune checkpoint inhibitors treatment Efficacy by CTCAE v5.0 pneumonitis grade Solubulate interleukin 2 receptor Bronchoalveolar lavage fluid

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. Histologically confirmed non-small cell lung cancer or maligmamt mesothelioma. 2. Patients who developed drug induced interstitial lung disease with CTCAE v5.0 grade 2 or 3 during immune checkpoint inhibitors (ICIs) or within 3 months from the last day of ICIs administrarion. 3. Required systemic corticosteroid therapy for drug induced interstitial lung disease. 4. The age is over 20 years. 5. Patients providing the written informed consent.
Exclude criteria1. Active comorbidity that has required continuous systemic corticosteroid or other immunosupressive agents 2. Patients with severe respiratory complication or received home oxygen therapy. 3. Patients with active infection. 4. Psychological disorder difficult to participate in this clinical study. 5. Uncontroled diabetes melitus 6. Female patients with pregnant. 7. Patients who recieve desmopressin. 8. Other immune related adverse events that has required systemic steroid therapy.

Related Information


Public contact
Name Shiozawa Toshihiro
Address 1-1-1 Tennodai, Tsukuba, Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3144
Affiliation Faculty of Medicine, University of Tsukuba
Scientific contact
Name Hizawa Nobuyuki
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3144
Affiliation University of Tsukuba Hospital