Japanese Intergroup Study of Nintedanib for NSCLC with IPF

JRCT ID: jRCTs071180049

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced Non-small cell lung cancer with idiopathic pulmonary fibrosis
• Date of first enrollment: 23/05/2017
• Target sample size: 240
• Study type: Interventional

Intervention(s)

carboplatin + nab-paclitaxel
carboplatin + nab-paclitaxel + nintedanib

Outcome(s)

• Primary Outcome: Exacerbation-free survival of IPF
• Secondary Outcome: Time to acute exacerbation of IPF, Frequency of patients with acute exacerbation of IPF, Rate of decline in FVC (expressed in mL over 12 weeks), Quality of life (QOL), Overall response rate (ORR), Progression-free survival (PFS) of non-small cell lung cancer, Time to treatment failure (TTF), Overall survival (OS), toxicity

Key inclusion & exclusion criteria

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

Include criteria

1) Written informed consent
2) 20 years of age or older
3) Histologically or cytologically proven non-small cell lung carcinoma
4) Clinical stage III, IV or recurrent disease after surgery
5) With or without measurable lesions
6) Without symptomatic central nervous system metastases
7) Without uncontrollable cardiac effusion, pleural effusion, ascites, superior vena cava syndrome or spinal cord compression
8) No prior chemotherapy
9) No history of treatment with nintedanib, nab-paclitaxel or immune checkpoint inhibitor
10) No prior operation under general anesthesia within 14 days before registration
11) No prior palliative radiotherapy within 14 days before registration
12) No prior biopsy under incision, thoracoscopic biopsy, or treatment for wound occurred within 7 days before registration
13) No prior blood transfusion or hematopoietic factor administration within 7 days before registration
14) No history of treatment with pirfenidone, cyclophosphamide, cyclosporine within 56 days before registration
15) No history of systemic treatment with steroid at a daily dose of more than 15mg in prednisolone equivalent.
16) Definite honeycomb lung destruction with basal and peripheral predominance or presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance.
17) DLCO 36% to 79% predicted of normal
18) FVC >/= 50% predicted of normal
19) SpO2 >/= 90% or PaO2 >/= 60 torr
under room air conditions
20) ECOG performance status of 0 or 1
21) Correspond to the following values in laboratory tests performed within 14 days before registration
a. Neutrophil count >/= 1,500 /mm3
b. Hemoglobin >/= 8.0 g/dL
c. Platelet count >/=100,000 /mm3
d. Total bilirubin </= 1.5 mg/dL
e. AST </= 100 IU/L
f. ALT </= 100 IU/L
g. Creatinine </= 2.0 mg/dL
h. PT-INR </= 2
i. Proteinuria </= Grade1 (CTCAE ver 4.0)

Exclude criteria

1) Ground glass opacity is less extensive than reticular opacity pattern
2) History of acute exacerbation of IPF
3) Other interstitial lung disease of known etiology including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vascular disease
4) Synchronous or metachronous active double malignancies
5) With serious complications
6) With high bleeding risks
7) Local or systemic active infection that requires treatment
8) Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study
9) Severe psychiatric diseases
10) History of serious drug allergies
11) Other conditions not suitable for this study

Related Information

• Primary Sponsor: Okamoto Isamu
• Secondary Sponsor: Otsubo Kohei
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd.