UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of immune checkpoint inhibitors among lung cancer patients with driver gene mutants
Acronym	The usefulness of immune checkpoint inhibitors among lung cancer patients with driver gene mutants
Scientific Title	The usefulness of immune checkpoint inhibitors among lung cancer patients with driver gene mutants
Scientific Title:Acronym	The usefulness of immune checkpoint inhibitors among lung cancer patients with driver gene mutants
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy and safety of immune checkpoint inhibitors among lung cancer patients with driver gene mutants
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Patients who enrolled the phase 2 or 3 clinical trials for the treatment with chemotherapy
Key exclusion criteria	Patients who excluded from clinical trials
Target sample size

Research contact person
Name of lead principal investigator	1st name Nobuaki Middle name Last name Kobayashi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Pulmonology
Zip code	236-0004
Address	Kanazawaku, Yokohama
TEL	+81453527962
Email	nkobayas@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Nobuaki Middle name Last name Kobayashi
Organization	Yokohama City University
Division name	Department of Pulmonogy
Zip code	236-0004
Address	Kanazawaku, Yokohama
TEL	+81453527962
Homepage URL
Email	nkobayas@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura, Kanazawaku, Yokohama
Tel	+81453527962
Email	nkobayas@yokohama-cu.ac.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	2020 Year 06 Month 16 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	Completed
Date of protocol fixation	2020 Year 06 Month 14 Day
Date of IRB	2020 Year 06 Month 26 Day
Anticipated trial start date	2020 Year 06 Month 14 Day
Last follow-up date	2020 Year 07 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study Search Studies will be systematically searched through PubMed, the Cochrane database, EMBASE, and Web of Science as of June 16, 2020. The search strategy for PubMed will be as follows: #1 non small cell lung cancer) #2 (immune checkpoint inhibitor [title] or nivolumab [title] or pembrolizumab [title] or atezolizumab [title] or durvalumab[title]) #1 and #2. Reference lists in the included articles and review articles will be also hand searched. Data synthesis The incidence of resistant mechanisms will be pooled. Synthesized data will be analyzed with each treatment. Statistical significance will be judged by P < 0.05.

Management information
Registered date	2020 Year 06 Month 16 Day
Last modified on	2020 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046578