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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000026799 |
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Date of registration:
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01/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis
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Scientific title:
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A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC) |
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Date of first enrolment:
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2017/05/12 |
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Target sample size:
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240 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030665 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shinichiro Nakamura |
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Address:
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Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
Japan |
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Telephone:
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06-6633-7400 |
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Email:
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datacenter@wjog.jp |
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Affiliation:
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West Japan Oncology Group WJOG datacenter |
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Name:
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Isamu Okamoto |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Japan |
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Telephone:
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090-642-5378 |
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Email:
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okamotoi@kokyu.med.kyushu-u.ac.jp |
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Affiliation:
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Kyushu University Research Institute for Diseases of the Chest |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion 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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Non-small-cell lung cancer with idiopathic pulmonary fibrosis
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Intervention(s)
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A: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks
B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single-agent administration of nintedanib (150 mg B.I.D, daily)
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Primary Outcome(s)
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Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non-small cell lung cancer is not treated as censored)
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Secondary Outcome(s)
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Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non-small cell lung cancer is treated as censored), Exacerbation-free survival 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
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Source(s) of Monetary Support
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Nippon Boehringer Ingelheim Co., Ltd.
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Ethics review
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Status: YES
Approval date: 12/05/2017
Contact:
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