UMIN-CTR Clinical Trial

Basic information
Public title	A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Acronym	Nivolumab for advanced sarcomatoid carcinoma of the lung
Scientific Title	A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Scientific Title:Acronym	Nivolumab for advanced sarcomatoid carcinoma of the lung
Region	Japan

Condition
Condition	advanced sarcomatoid carcinoma of the lung
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To confirm effect and safety of nivolumab in patients with advanced sarcomatoid carcinoma of the lung.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate by Central review
Key secondary outcomes	Overall response rate by investigator, PFS, OS, DCR, Survival rate at 6 months, and toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed sarcomatoid carcinoma of the lung 2. Stage III, IV, and postoperative recurrence 3. Age > 20 4. PS 0-2 5. Measurable lesion 6. Adequate organ function 7. Written informed consent
Key exclusion criteria	1. Active auto-immune disease 2. Interstitial lung disease or pulmonary fibrosis 3. Active infection such as bacteria, HBV, or HCV
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Ohe
Organization	National Cancer Center Hospital
Division name	Department of Thoracic Oncology
Zip code	104-0045
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	yohe@ncc.go.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Fujiwara
Organization	National Cancer Center Hospital
Division name	Department of Thoracic Oncology
Zip code	104-0045
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	yutakafu@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	National Cancer Center 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	National Cancer center Hospital
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	yutakafu@ncc.go.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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 23 Day
Date of IRB	2017 Year 02 Month 23 Day
Anticipated trial start date	2017 Year 03 Month 27 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 01 Day
Last modified on	2020 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026982