PROTECT trial

JRCT ID: jRCTs051220082

Registered date:30/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild drug-induced pneumonitis
• Date of first enrollment: 12/09/2022
• Target sample size: 106
• Study type: Interventional

Intervention(s)

Both the standard treatment group and the study treatment group will receive prednisolone treatment according to the prescribed dosing schedule by body weight, as described in the protocol. The observation period will be 56 days from the date of steroid initiation.
Study treatment group: 3-week steroid group
Prednisolone treatment is completed in 3 weeks according to the prescribed dosage schedule according to the procedure described in the protocol.
Standard treatment group: 6-week steroid group
Prednisolone treatment is completed in 6 weeks according to the prescribed dosage schedule according to the procedure described in the protocol.

Outcome(s)

• Primary Outcome: Percentage of patients showing improvement
• Secondary Outcome: Safety, percentage of patients with exacerbation, time to exacerbation, time to end of steroids, quality of life, overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Informed written consent before enrollment in the study.
2) At least 20 years of age at the time consent is obtained.
3) Drug-induced pneumonitis has been diagnosed by at least two physicians.
4) Drug-induced pneumonitis of Grade 1 or 2 (CTCAE ver.5.0) which developed during or after immune checkpoint inhibitor-included therapy.
5) More than 3 months since completion of chest radiation.
6) Weighing at least 30 kg.
7) Expected to live despite cancer for at least 12 weeks at the time of enrollment.
8) ECOG PS of 0-2.
9) Transcutaneous oxygen saturation (SpO2) >= 93% with room air at rest.
10) Meeting the following laboratory criteria within 8 days prior to enrollment
Neutrophil count >= 1000 /mm3
Hemoglobin >= 7.0 g/dL
Platelet count >= 50,000 /uL
Creatinine level < 3.0 mg/dl

Exclude criteria

Patients who meet any of the following criteria are ineligible
1) Disease or condition that may interfere with their ability to understand, perform or comply with study procedures.
2) Active tuberculosis (latent tuberculosis is not considered active).
3) Have undergone surgery within 28 days prior to enrollment or are expected to require surgery within 56 days of the start of study treatment (excluding minor surgery such as drain placement or tooth extraction).
4) Patients who received systemic administration of corticosteroids or other immunosuppressive agents (e.g., prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents) within 14 days before enrollment.
Mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose steroid replacement for adrenocortical insufficiency are acceptable.
5) Current or past autoimmune diseases with possible interstitial lung complications (inflammatory bowel disease [e.g., ulcerative colitis or Crohn's disease], systemic lupus erythematosus, dermatomyositis, scleroderma, Sjogren's syndrome, and
Patients with confirmed sarcoidosis, polyangitis granulomatosa, mixed connective tissue disease, vasculitis syndrome, rheumatoid arthritis, etc.). However, the following are eligible for inclusion:
-Patients with vitiligo or alopecia vulgaris.
-Patients with hypothyroidism (e.g., Hashimoto's disease) that has been stabilized by hormone replacement therapy.
-Chronic skin diseases that do not require systemic treatment.-Patients whose disease has not progressed rapidly within the past 5 years at the time of enrollment may be eligible for inclusion. However, this is limited to cases discussed by the Principal Investigator.
In the case of an autoimmune disease not listed above, the Principal Investigator will discuss the case and decide whether or not the patient can be enrolled.
6) History of significant cardiovascular disease (e.g., NYHA Class III or higher heart disease, myocardial infarction within the past 3 months, uncontrolled arrhythmia)
7) Uncontrolled pleural, ascites, or pericardial effusions
In case of drainage for >24 hours, it must have been at least 7 days since the drainage was stopped (drainage on the same day of the week before the registration date is acceptable), and no Grade 3 or higher fluid retention has been observed since the drainage was stopped.
No exacerbation after drain removal is acceptable.
8) Diabetes mellitus that is poorly controlled by appropriate treatment.
9) Patients requiring steroid therapy for purposes other than drug-induced pneumonitis (excluding replacement therapy).
10) Grade 3 or higher immune-related adverse events.
11) Otherwise deemed inappropriate for participation in the study by the treating physician.

Related Information

• Primary Sponsor: Akamatsu Hiroaki