UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of the effectiveness and safety of nivolumab for non-small cell lung cancer patients: a retropective cohort study
Title of the study (Brief title)	The effectiveness and safety of nivolumab for non-small cell lung cancer patients
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and safety of nivolumab for non-small cell lung cancer patients in clinical setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	adverse events response rate overall survival

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 advanced non-small cell lung cancer Treated with nivolumab after second line from 1/2016 to the date of institutional review board approval
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	Yuki Kataoka
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine
Address	Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo
TEL	06-6480-7000
Email	youkitikk@gmail.com

Public contact
Name of contact person	Yuki Kataoka
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine
Address	Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo
TEL	06-6480-7000
Homepage URL
Email	youkitikk@gmail.com

Sponsor
Institute	Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center
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	兵庫県立尼崎総合医療センター（兵庫県） 地域医療機能推進機構大阪病院（大阪府） 市立伊丹病院（兵庫県） 神戸市立医療センター中央市民病院（兵庫県） 倉敷中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 21 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 04 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	Partially published
URL releasing results	https://academic.oup.com/annonc/article-abstract/3076095/Prior-radiotherapy-does-not-predict-nivolum
Results
Other related information	We will analyse following variables: age, gender, pathological type, stage, EGFR mutation, ALK translocation, comorbidity, CBC, chemistry.

Management information
Registered date	2016 Year 04 Month 21 Day
Last modified on	2017 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025371