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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-jRCTs031190084 |
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Date of registration:
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27/08/2019 |
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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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TORG1936 / AMBITIOUS study
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Scientific title:
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A phase II study of Atezolizumab for advanced / recurrent Non-Small Cell Lung Cancer with Idiopathic Interstitial Pneumonias - TORG1936 / AMBITIOUS study |
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Date of first enrolment:
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05/09/2019 |
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Target sample size:
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38 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs031190084 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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Terufumi
KATO |
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Address:
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2-3-2 Nakao, Asahi-ku, Yokohama
241-8515
Kanagawa
Japan |
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Telephone:
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+81-45-520-2222 |
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Email:
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terufumikato@gmail.com |
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Affiliation:
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Kanagawa Cancer Center |
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Name:
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Satoshi
IKEDA |
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Address:
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6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama
236-0051
Kanagawa
Japan |
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Telephone:
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+81-45-701-9581 |
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Email:
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isatoshi0112@gmail.com |
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Affiliation:
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Kanagawa Cardiovascular and Respiratory Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer
2)Unresectable stage 3/4 or recurrent
3)Received prior chemotherapy including platinum doublet
4)Chronic fibrotic IP
HRCT revealed (1) reticular shadow with basal and peripheral predominance suggestive of UIP pattern,or(2) peri-bronchovascular shadow suggestive of NSIP pattern
lOther interstitial lung disease of known etiology(infection, pneumoconiosis, drug, sarcoidosis, and collagen vascular disease)
l%FVC>70%
l%DLCO>35%
5)Age>=20 years
6)ECOG Performance Status 0-1
7)With measurable or evaluable lesions according to RECIST Version1.1
8)Vital organ functions are preserved
9)Received sufficient explanations about the name and severity of the illness
10) Written informed consent
Exclusion criteria: 1)History of acute exacerbation of IPF
2)Treatment history with immune-checkpoint inhibitor
3)Systemic treatment with steroids at a daily dose>10mg of prednisolone equivalent or immunosupressants
4)Active autoimmune disease or history of autoimmune disease requiring treatment
5)Symptomatic brain metastasis or spinal cord metastases
6)Active viral hepatitis
7)Active infection
8)Synchronous or metachronous active double malignancies
9)Pregnant or breastfeeding
10) Disapprove of contraception during the protocol treatment period
11) Treatment history with thoracic radiotherapy
12) History of serious drug allergies
13) Other conditions not suitable for the study
Age minimum:
>= 20age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced / recurrent Non-small cell lung cancer with idiopathic interstitial pneumonia
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Intervention(s)
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Atezolizumab 1200mg, every 3 weeks
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Primary Outcome(s)
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1 year-survival rate
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Secondary Outcome(s)
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The incidence of acute exacerbation of IP within 1 year after treatment initiation, overall survival, progression free survival, objective response rate, time to treatment failure, mortality rate due to acute exacerbation of IP or pneumonitis during observation period, safety
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Source(s) of Monetary Support
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Thoracic Oncology Research Group
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Ethics review
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Status: Approval
Approval date: 23/07/2019
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
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