UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Malutiple-institutional observational surveillance of Pembrolizumab as a first line treatment for non-small cell lung cancer
Title of the study (Brief title)	Observational surveillance of Pembrolizumab as a 1st line treatment for NSCLC
Region	Japan

Condition
Condition	non small cell lung cancer
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate of factors influencing the response rate and adverse reactions to an immune checkpoint inhibitor, as well as subsequent therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate whether obsertive analysis of nivolumab therapy in the real clinical setting reproduces the RR shown by primary analysis of the KeyNote-024 trial.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with a definite diagnosis of NSCLC based on histology or cytology. 2) Patients unsuitable for curative radiation therapy who have a clinical diagnosis of either recurrent disease or stage IV NSCLC. 3) Patients who receive at least one dose of pembrolizumab.
Key exclusion criteria	1)Patients who have previously received pembrolizumab in a clinical trial will be excluded 2)Pretreated chemotherapy
Target sample size	150

Research contact person
Name of lead principal investigator	Tamiya Motohiro
Organization	Osaka International Cancer Institute
Division name	Thoracic Oncology
Address	3-1-69 Otemae Chuo-ku Osaka
TEL	06-6945-1181
Email	moto19781205@yahoo.co.jp

Public contact
Name of contact person	Fujimoto Daichi
Organization	Kobe City Medical Center General Hospital
Division name	Respiratory Medicine
Address	2-1-1 Minatojimaminamicho Chuo-ku Kobe
TEL	078-302-4321
Homepage URL
Email	daichianzen@yahoo.co.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
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	独立行政法人国立病院機構近畿中央胸部疾患センター　大阪はびきの医療センター 神戸市立医療センター中央市民病院　 兵庫県立尼崎総合医療センター　 公益財団法人大原記念倉敷中央医療機構　倉敷中央病院神戸市立医療センター西市民病院　 独立行政法人国立病院機構 姫路医療センター 大阪国際がんセンター 独立行政法人国立病院機構　刀根山病院　 大阪急性期総合医療センター　 市立伊丹病院

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 05 Month 04 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	Case control study. We will assess clinical demographic, diagnosis, histological subtypes, treatment of pembrolizumab, clinical outcome (response, time-to-event), or laboratory data.

Management information
Registered date	2018 Year 05 Month 04 Day
Last modified on	2018 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037024