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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs031190119
• Date of registration: 18/10/2019
• Prospective Registration: Yes
• Primary sponsor: IKEDA Satoshi
• Public title: A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPF
• Scientific title: A Phase II Study of Carboplatin and Etoposide Plus Nintedanib for Unresectable Limited/Extensive Disease Small Cell Lung Cancer with Idiopathic Pulmonary Fibrosis - TORG1835 / NEXT-SHIP
• Date of first enrolment: 28/10/2019
• Target sample size: 33
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs031190119
• Study type: Interventional
• Study design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
• Phase: 2

Contacts

• Name: Satoshi IKEDA
• Affiliation: Kanagawa Cardiovascular and Respiratory Center

• Name: Satoshi IKEDA
• Affiliation: Kanagawa Cardiovascular and Respiratory Center

Key inclusion & exclusion criteria

Inclusion 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
Exclusion 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

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

Health Condition(s) or Problem(s) studied

Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosis

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.

Primary Outcome(s)

the incidence of acute exacerbation of IPF at 28 days after last administration of cytotoxic anti-cancer agents (carboplatin and etoposide)

Secondary Outcome(s)

Time to first acute exacerbation of IPF, ORR, PFS, OS, and toxicities

Source(s) of Monetary Support

Japan Reserch Foundation Clinical Pharmacology

Japanese Respiratory Foundation Grant (2018)

Research grant from Cancer Research Fund of Kanagawa Prefectural Hospital Organization

Secondary Sponsor(s)

OGURA Takashi

Thoracic Oncology Research Group

Ethics review

Status: Approval
Approval date: 26/08/2019
Contact:

[e-mail]

Niigata University Central Review Board of Clinical Research

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