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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 11 August 2020
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: Recruiting
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
Countries of recruitment
Japan
Contacts
Name: Satoshi    IKEDA
Address:  Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Kanagawa 236-0051 Kanagawa Japan
Telephone: +81-45-701-9581
Email: isatoshi0112@gmail.com
Affiliation:  Kanagawa Cardiovascular and Respiratory Center
Name: Satoshi    IKEDA
Address:  Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Kanagawa 236-0051 Kanagawa Japan
Telephone: +81-45-701-9581
Email: isatoshi0112@gmail.com
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
Secondary ID(s)
Source(s) of Monetary Support
Japanese Respiratory Foundation Grant (2018)
Secondary Sponsor(s)
OGURA Takashi
Thoracic Oncology Research Group
Ethics review
Status: Approval
Approval date: 26/08/2019
Contact:
crbcr@adm.niigata-u.ac.jp
Niigata University Central Review Board of Clinical Research
+81-25-368-9343
crbcr@adm.niigata-u.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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