UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs.
Title of the study (Brief title)	IP-NSCLC nivolumab study
Region	Japan

Condition
Condition	Advanced NSCLC patients with IIPs
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate safety and efficacy of nivolumab in advanced NSCLC with IIPs
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Response rate, progression free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nivolumab 3mg/kg, every 2 weeks
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1)Pathologically proven NSCLC 2)Subjects with IIPs which meets the criteria below I)VC is more than 80 percent of predicted II)Possible UIP or inconsistent UIP 3)Advanced stage 4)Second line or beyond 5)No IIPs worsening due to previous chemotherapy
Key exclusion criteria	1)Subjects with the history of drug induced pneumonitis 2)Subjects with definite UIP pattern 3)Subjects with serious infection 4)Subjects with serious complications 5)Subjects with symptomatic brain metastases 6)Subjects with uncontrolled pleural effusion, ascites, and pericardial effusion
Target sample size	6

Research contact person
Name of lead principal investigator	Keisuke Tomii
Organization	Kobe city medical center general hospital
Division name	Division of respiratory medicine
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL	078-302-4321
Email	ktomii@kcho.jp

Public contact
Name of contact person	Daichi Fujimoto
Organization	Kobe city medical center general hospital
Division name	Division of respiratory medicine
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL	078-302-4321
Homepage URL
Email	daichi@kcho.jp

Sponsor
Institute	Kobe city medical center general hospital
Institute
Department

Funding Source
Organization	Kobe city medical center general hospital
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 04 Month 19 Day
Last follow-up date	2017 Year 01 Month 21 Day
Date of closure to data entry	2017 Year 02 Month 14 Day
Date trial data considered complete	2017 Year 02 Month 14 Day
Date analysis concluded	2017 Year 03 Month 01 Day

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

Management information
Registered date	2016 Year 04 Month 24 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024914