UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of biomarkers to predict immune-related adverse events in patients with non-small cell lung cancer
Acronym	Biomarkers to predict irAEs in patients with NSCLC
Scientific Title	Investigation of biomarkers to predict immune-related adverse events in patients with non-small cell lung cancer
Scientific Title:Acronym	Biomarkers to predict irAEs in patients with NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigation for molecular markers that enable the prediction or early detection of immune-related adverse events in the combination of chemotherapy and immunotherapy for non-small cell lung cancer
Basic objectives2	Others
Basic objectives -Others	Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset of drug-induced interstitial lung disease
Key secondary outcomes	Onset of immune-related adverse events

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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The age at the time of obtaining consent is 20 years or older. 2. Diagnosed as non-small cell lung cancer. 3. chemo-IO is planned. 4. Expected to survive for more than 6 months after registration. 5. Written consent is obtained.
Key exclusion criteria	1. Patients with active double cancer (simultaneous double cancer and metachronous double cancer with no disease period within 3 years). 2. Patients with ILD complications prior to treatment (Intestinal Lung Abnormality (ILA) is acceptable). 3. Patients with autoimmune disease. 4. Patients taking 10 mg or more of prednisolone. 5. Patients who the principal investigator deems inappropriate for this study.
Target sample size	114

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Nagano
Organization	Kobe University Hospital
Division name	Respiratory Medicine
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL	0783825660
Email	tnagano@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Nagano
Organization	Kobe University Hospital
Division name	Respiratory Medicine
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL	0783825660
Homepage URL
Email	tnagano@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Self-funding
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 University Hospital Clinical Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel	0783826669
Email	kansatsu@med.kobe-u.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	2022 Year 05 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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 01 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Peripheral blood is collected before the start of chemo-IO and after 1 week, 6 weeks, and 21 weeks.

Management information
Registered date	2022 Year 03 Month 13 Day
Last modified on	2022 Year 03 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053799