UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Acronym	The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Scientific Title	The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Scientific Title:Acronym	The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Region	Japan

Condition
Condition	non-small cell lung cancer interstitial lung disease interstitial pneumonia
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	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	overall survival, response rate, duration of response, safety

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	18

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name Tomii
Organization	Kobe city medical center general hospital
Division name	Division of respiratory medicine
Zip code	650-0047
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	1st name Daichi Middle name Last name Fujimoto
Organization	Kobe city medical center general hospital
Division name	Division of respiratory medicine
Zip code	650-0047
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)

IRB Contact (For public release)
Organization	Kobe city medical center general hospital
Address	2-1-1, minatojima-minamimachi, chuo-ku, Kobe
Tel	078-302-4321
Email	rinken@kcho.jp

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	神戸市立医療センター西市民病院 神奈川県立循環器呼吸器病センター 東京都立駒込病院

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 15 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/31182249
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/31182249
Number of participants that the trial has enrolled	18
Results	Results: Eighteen patients were enrolled in this trial. Six months PFS rate was 56%, response rate was 39%, and disease control rate was 72%. There were no treatment-related deaths. One drug-related grade 3/4 nonhematologic event (grade 3 neurotoxicity) was observed. Two patients had grade 2 pneumonitis which improved by corticosteroid therapy. Conclusions: Nivolumab could be an effective therapy for NSCLC patients with mild IIPs.
Results date posted	2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Eligible patients had previously-treated, inoperable NSCLC with mild IIPs.
Participant flow	Eligible patients had previously-treated, inoperable NSCLC with mild IIPs.
Adverse events	One drug-related grade 3/4 nonhematologic event (grade 3 neurotoxicity) was observed. Two patients had grade 2 pneumonitis which improved by corticosteroid therapy.
Outcome measures	Six months PFS rate was 56%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 13 Day
Date of IRB	2017 Year 02 Month 13 Day
Anticipated trial start date	2017 Year 02 Month 14 Day
Last follow-up date	2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 12 Month 28 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2022 Year 01 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029759