UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of efficacy and safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia
Title of the study (Brief title)	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	Osamu Kanai
Organization	National Health Organization Kyoto Medical Center
Division name	Respiratory Medicine
Address	1-1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL	075-641-9161
Email	geminus75@gmail.com

Public contact
Name of contact person	Osamu Kanai
Organization	National Health Organization Kyoto Medical Center
Division name	Respiratory Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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