UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034849 |
|---|---|
| Receipt number | R000037986 |
| Scientific Title | A prospective study of efficacy and safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia |
| Date of disclosure of the study information | 2018/11/12 |
| Last modified on | 2018/11/10 11:22:09 |
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Basic information
Public title
A prospective study of efficacy and safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia
Acronym
Atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia
Scientific Title
A prospective study of efficacy and safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia
Scientific Title:Acronym
Atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of drug-induced pneumonitis during the initial and one month after the last administration of atezolizumab
Key secondary outcomes
Response rate and disease control rate of atezolizumab
Progression-free and overall survival time from the initiation of atezolizumab
Incidences of any adverse events from the initiation of atezolizumab
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologically confirmed the diagnosis of non-small cell lung cancer
Advanced (unresectable) or recurrent after resection
Refractory to one or more chemotherapeutic regimens and planned to be treated with atezolizumab
A score of ECOG-PS is 0 to 2
The findings which are suspicious to interstitial pneumonia such as reticular opacity or fibrotic change are observed in two or more lobes of the lung confirmed by the CT performed within one month until the initiation of atezolizumab.
Key exclusion criteria
Severe renal dysfunction (eGFR < 30 ml/min/1.73m2)
Severe liver dysfunction (AST > 100 IU/ml, ALT > 100 IU/ml, or T-Bil > 3 mg/dl)
Respiratory failure (PaO2 < 60 mmHg or PaCO2 >45 mmHg on under room air atmosphere)
Prior history of acute exacerbation of interstitial pneumonia or drug-induced pneumonitis
Impossibility to obtain a written consent form
Impossibility to obtain sufficient data of outcomes
Judgement of unsuitability as a subject from researchers
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Kanai |
Organization
National Health Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
Address
1-1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL
075-641-9161
geminus75@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Kanai |
Organization
National Health Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
Address
1-1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
geminus75@gmail.com
Sponsor or person
Institute
National Health Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人国立病院機構 京都医療センター (京都府)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 11 | Month | 10 | Day |
Last modified on
| 2018 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037986
