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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048096
Receipt No. R000054763
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)
Date of disclosure of the study information 2022/06/18
Last modified on 2022/06/18

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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