Nintedanib for IPF patients with resected NSCLC in JAPAN Phase 2 study

JRCT ID: jRCT1061220064

Registered date:20/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Idiopathic pulmonary fibrosis, Non-Small Cell Lung Cancer
• Date of first enrollment: 23/01/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Product name: Ofev Capsules 100 mg, Ofev Capsules 150 mg
Generic name: nintedanib ethanesulfonate
The usual adult dosage of nintedanib is 150 mg twice daily, orally administered after breakfast and dinner. The dose may be reduced to 100 mg of nintedanib twice daily depending on the patient's condition.

Outcome(s)

• Primary Outcome: Percentage of patients who remained on study drug by 26 weeks (Tolerability)

Secondary Outcome

Percentage of patients who remained on study drug by 52 weeks (Tolerability)
Percent change in respiratory function (FVC) at 26 weeks after study drug administration
Respiratory function change at 52 weeks (FVC)
52-week survival rate (Overall survival)
Recurrence-free survival at 52 weeks
Acute exacerbation rate of interstitial pneumonia up to 52 weeks
Incidence of 10% decline in respiratory function (FVC) or death at 52 weeks after enrollment
Adverse event rate
Serious adverse event rate

Key inclusion & exclusion criteria

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

Include criteria

1. who are at least 20 years of age at the time of consent
2. meet the diagnostic criteria for IPF (attached) within 1 year of incorporation and all of the following
(1) High-resolution CT findings or pathological findings are determined to be either UIP pattern, Probable UIP pattern, or Indeterminate for UIP pattern based on the ATS/ERS/JRS/ALAT 2018 International Classification11 (must be documented in either the radiology report, histopathology report, or medical record). (This must be noted in either the radiology report, histopathology report, or medical record).
The patient does not have interstitial lung disease (ILD) with an obvious cause such as collagen disease, drug-induced, sarcoidosis, hypersensitivity pneumonitis, etc. The diagnosis of idiopathic pulmonary fibrosis (IPF) should be made comprehensively by a radiologist, a respiratory physician, and a pathologist.
Central judgment of imaging and pathology in the diagnosis of IPF
In this study, the diagnosis of idiopathic pulmonary fibrosis (IPF) will be made based on preoperative high-resolution CT findings and histopathological findings of lung resection specimens. Because the diagnosis of idiopathic pulmonary fibrosis (IPF) is difficult and some variation in institutional diagnosis can be expected, it was decided to perform a central determination of imaging and pathology. The items for central determination include the diagnosis of idiopathic pulmonary fibrosis (IPF) (IPF/IPF(Likely)/Indeterminate/Non-IPF) using the lung fields of high-resolution CT and the background lungs of pathology specimens. For the above items, the percentage of agreement between the institutional judgment and the central judgment will be examined. This will be done in accordance with the Central Judgment Procedure.
3. Patients with a diagnosis of stage 1-3 non-small cell lung cancer based on clinical and pathological diagnosis after pneumonectomy.
4. have pathologically confirmed complete resection (R0) in the surgically resected specimen.
Complete resection is defined as grossly and histologically complete resection of lung cancer. If there is histological evidence of residual cancer, it is "incomplete resection.
5. No serious adverse events (Grade 3 or higher by CTCAE criteria or acute exacerbation of interstitial pneumonia) within 30 days after lung resection.
6. patients with Grade 1-2 adverse events by CTCAE criteria within 30 days of pneumonectomy, if, in the judgment of the treating physician, participation in the study would not be detrimental to the patient.
7. performance status (PS) is 0 or 1 according to ECOG criteria. (PS must be documented in the medical record)
8.No prior chemotherapy within 2 years, including other types of cancer. Perioperative chemotherapy for curatively resected non-small cell lung cancer is not actively recommended, but may be administered and is not an exclusion criterion.
9. latest laboratory values within 30 days prior to enrollment (the same day of the week 4 weeks prior to the date of enrollment is acceptable) meet all of the following
(1) White blood cell count > 3,000 /mm3 (2) Hemoglobin > 10.0 g/dL (3) Platelet count > 15 x 104 /mm3
No ischemic changes on the latest 12-lead ECG at rest within 60 days prior to enrollment. However, if ischemic changes are detected on 12-lead EKG, the patient will be considered eligible if it is determined that treatment for ischemic heart disease is not necessary after performing echocardiography, exercise stress EKG, or other tests.
11. Respiratory function tests performed within 60 days before lung resection must meet the following criteria.
1) Preoperative %FVC is greater than or equal to 60%.
2) Preoperative %DLco is greater than or equal to 40%.
12. Patients must give written consent to participate in this study.
13. Patinets have the above eligibility confirmed within 60 days after lung resection.

Exclude criteria

1, Patients with elevated AST or ALT or total bilirubin >1.5x ULN.
2, Patients with renal disease (serum Cr > 1.5 mg/dL or CKD stage 3 or higher).
3, Patients with the following complications.
3, Patients with the following complications: hepatic disease, psychiatric disease, seizure or paroxysmal disorder, history or predisposition to thromboembolism, and patients receiving anticoagulant therapy.
4, Patients with a history of serious adverse reactions to nintedanib.
5, Patients who meet any of the contraindications to the administration of nintedanib.
6, Pregnant and lactating women, women who may be pregnant, or women who wish to have a baby.
7, Patients who have received anti-fibrotic drugs within 60 days prior to enrollment.
8, Patients who are deemed to interfere with, limit, or confound the evaluation specific to the clinical research protocol.
9, Employees of the Principal Investigator or other investigators or the site of the study who are directly involved in this or other clinical research, or family members of such employees or Principal Investigators.

Related Information

• Primary Sponsor: Okada Morihito