UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter retrospective observational study evaluating the safety and efficacy of immune checkpoint inhibitors in patients with advanced or recurrent lung cancer after COVID-19 vaccination (NEJ061)
Acronym	NEJ061 study
Scientific Title	A multicenter retrospective observational study evaluating the safety and efficacy of immune checkpoint inhibitors in patients with advanced or recurrent lung cancer after COVID-19 vaccination (NEJ061)
Scientific Title:Acronym	NEJ061 study
Region	Japan

Condition
Condition	advanced or recurrent lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of immune checkpoint inhibitors (ICIs) in patients with advanced or recurrent lung cancer after COVID-19 vaccinations
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of Grade 3 or higher immune-related adverse events
Key secondary outcomes	Progression-free survival 6 months after ICI administration Incidence of immune-related adverse events in all grades Objective response rate Exacerbation rate of existing immune-related adverse events Side effects of the vaccination Efficacy of the vaccination

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. histologically or cytologically confirmed lung cancer 2. incapable of definitive radiation therapy Stage IIIB / IIIC / IV or postoperative recurrence 3. receiving treatments started between January and October 2021 with immune checkpoint inhibitors such as: In case of non-small cell lung cancer - Nivolumab, pembrolizumab, or atezolizumab alone - Nivolumab + ipilimumab (+ platinum combination therapy) - Pembrolizumab + platinum combination therapy - Atezolizumab + platinum combination therapy In case of high-grade neuroendocrine cancer - Atezolizumab (+ platinum combination therapy) - Durvalumab (+ platinum combination therapy) 4. ECOG PS 0-2
Key exclusion criteria	1. active concomitant malignancy 2. interstitial pneumonia or pulmonary fibrosis detectable on CT scan 3. re-administration of immune checkpoint inhibitors (previously PD or toxic discontinuation) 4. with active hepatitis B or hepatitis C 5. with autoimmune disease or a history of autoimmune disease requiring steroid therapy 6. other than autoimmune diseases, continuous systemic or intravenous administration of steroids at doses higher than 10 mg / day in terms of prednisolone is required, and immunosuppressants are used 7. with a history of human immunodeficiency virus
Target sample size	850

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Minegishi
Organization	Mitsui Memorial Hospital
Division name	Respiratory medicine
Zip code	101-8643
Address	Kanda-Izumi-cho 1,Chiyoda-ku,Tokyo 101-8643
TEL	03-3862-9111
Email	minegishi-yuji@mitsuihosp.or.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Shiraishi
Organization	Mitsui Memorial Hospital
Division name	Respiratory medicine
Zip code	101-8643
Address	Kanda-Izumi-cho 1,Chiyoda-ku,Tokyo 101-8643
TEL	03-3862-9111
Homepage URL
Email	shiraishi-hideaki@mitsuihosp.or.jp

Sponsor
Institute	Specified Nonprofit Corporation North East Japan Study Group
Institute
Department

Funding Source
Organization	Specified Nonprofit Corporation North East Japan Study Group
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	Mitsui Memorial Hospital Medical Ethics Committee
Address	Kanda-Izumi-cho 1,Chiyoda-ku,Tokyo 101-8643
Tel	03-3862-9111
Email	c-uno@mitsuihosp.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NEJ061
Org. issuing International ID_1	Specified Nonprofit Corporation North East Japan Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学病院（北海道）、弘前大学医学部附属病院（青森県）、秋田厚生医療センター（秋田県）、大曲厚生医療センター（秋田県）、坂総合病院（宮城県）、東北大学病院（宮城県）、仙台厚生病院（宮城県）、獨協医科大学日光医療センター（栃木県）、栃木県立がんセンター（栃木県）、佐野厚生総合病院（栃木県）、筑波大学附属病院（茨城県）、埼玉医科大学国際医療センター（埼玉県）、日本医科大学千葉北総病院（千葉県）、日本医科大学付属病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、三井記念病院（東京都）、江東病院（東京都）、杏林大学医学部付属病院（東京都）、東邦大学医療センター大森病院（東京都）、国立病院機構　災害医療センター（東京都）、聖マリアンナ医科大学病院（神奈川県）、新潟大学医歯学総合病院（新潟県）、徳島大学病院（徳島県）、島根大学医学部附属病院（島根県）、JA尾道総合病院（広島県）、広島大学病院（広島県）、山口県済生会下関総合病院（山口県）

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 18 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	850
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	2022 Year 05 Month 24 Day
Date of IRB	2022 Year 06 Month 06 Day
Anticipated trial start date	2022 Year 06 Month 06 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry	2022 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other

Other related information

We conduct a multicenter retrospective observational study to evaluate the above endpoints for advanced / recurrent lung cancer patients that started treatment with immune checkpoint inhibitors between January 2021 and October 2021. -Compare the vaccinated group and the unvaccinated group -All patients who meet the eligibility criteria will be enrolled, but patients with insufficient data will be excluded from the analysis. -The observation period is 6 months from the start of ICI in principle. (In case of vaccinated patients, 6 months from vaccination If ICI precedes and 6 months from ICI initiation If vaccine precedes)

Management information
Registered date	2022 Year 06 Month 18 Day
Last modified on	2022 Year 06 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054763