A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPF

JRCT ID: jRCTs031190119

Registered date:18/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosis
• Date of first enrollment: 28/10/2019
• Target sample size: 33
• Study type: Interventional
• Intervention(s): The patients receive carboplatin(area under the curve 5 mg/mL, intravenously, day 1), etoposide (<75 years old:100mg/m2:>=75years old:80mg/m2;intravenously,days 1-3), and nintedanib (150mg twice a day, orally). The patients receive combination chemotherapy every3 weeks for 4 cycles until disease progression or unacceptable toxicity occurs. After completion or discontinuation of carboplatin plus etoposide, the patients continue nintedanib until the discontinuation criteria are satisfied.

Outcome(s)

• Primary Outcome: the incidence of acute exacerbation of IPF at 28 days after last administration of cytotoxic anti-cancer agents (carboplatin and etoposide)
• Secondary Outcome: Time to first acute exacerbation of IPF, ORR, PFS, OS, and toxicities

Key inclusion & exclusion criteria

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

Include criteria

1. Histologically or cytologically proven small cell lung cancer
2. Unresectable limited disease or extensive disease
3. No previous chemotherapy for small cell lung cancer
4. HRCT reveal (1) Definite honeycomb lung destruction with basal and peripheral predominance : or (2) Presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance
5. % FVC >= 50 , % DLCO >= 30 %
6. Age >= 20 years
7. ECOG Performance Status 0-2
8. With measurable lesions according to RECIST Version1.1
9. Vital organ functions are preserved
10.Received sufficient explanations about the name and severity of the illness
11. Written informed consent

Exclude criteria

1.Ground glass opacity pattern less extensive than reticular opacity pattern
2.Other interstitial lung disease of known etiology (including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vascular disease)
3.History of acute exacerbation of IPF
4.Synchronous or metachronous active double malignancies
5.Symptomatic brain metastasis or spinal cord metastases
6.Treatment history with pirfenidone, immunosuppressants, and N-acetylcysteine within 56 days before registration
7.Treatment history with nintedanib, cytotoxic chemotherapy, and immune checkpoint inhibitors
8.High hemorrhage risk
9.Serious complications
10.Local or systemic active infection requiring treatment
11.Pregnant, possibly pregnant, breastfeeding
12.History of serious drug allergies
13.Systemic treatment with steroids at a daily dose >10 mg of prednisolone equivalent
14.Other conditions not suitable for the study

Related Information

• Primary Sponsor: IKEDA Satoshi
• Secondary Sponsor: OGURA Takashi,Thoracic Oncology Research Group
• Source(s) of Monetary Support: Japanese Respiratory Foundation Grant (2018),Research grant from Cancer Research Fund of Kanagawa Prefectural Hospital Organization,Japan Reserch Foundation Clinical Pharmacology