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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034849
Receipt No. 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

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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
Email 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
Email geminus75@gmail.com

Sponsor
Institute National Health Organization Kyoto Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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