Unique ID issued by UMIN | UMIN000048096 |
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Receipt number | 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 12:55:02 |
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)
NEJ061 study
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)
NEJ061 study
Japan |
advanced or recurrent lung cancer
Pneumology |
Malignancy
NO
To evaluate the safety and efficacy of immune checkpoint inhibitors (ICIs) in patients with advanced or recurrent lung cancer after COVID-19 vaccinations
Safety,Efficacy
Confirmatory
Others
Not applicable
Incidence of Grade 3 or higher immune-related adverse events
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
850
1st name | Yuji |
Middle name | |
Last name | Minegishi |
Mitsui Memorial Hospital
Respiratory medicine
101-8643
Kanda-Izumi-cho 1,Chiyoda-ku,Tokyo 101-8643
03-3862-9111
minegishi-yuji@mitsuihosp.or.jp
1st name | Hideaki |
Middle name | |
Last name | Shiraishi |
Mitsui Memorial Hospital
Respiratory medicine
101-8643
Kanda-Izumi-cho 1,Chiyoda-ku,Tokyo 101-8643
03-3862-9111
shiraishi-hideaki@mitsuihosp.or.jp
Specified Nonprofit Corporation North East Japan Study Group
Specified Nonprofit Corporation North East Japan Study Group
Other
Mitsui Memorial Hospital Medical Ethics Committee
Kanda-Izumi-cho 1,Chiyoda-ku,Tokyo 101-8643
03-3862-9111
c-uno@mitsuihosp.or.jp
YES
NEJ061
Specified Nonprofit Corporation North East Japan Study Group
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)
2022 | Year | 06 | Month | 18 | Day |
Unpublished
850
No longer recruiting
2022 | Year | 05 | Month | 24 | Day |
2022 | Year | 06 | Month | 06 | Day |
2022 | Year | 06 | Month | 06 | Day |
2022 | Year | 07 | Month | 31 | Day |
2022 | Year | 07 | Month | 31 | Day |
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)
2022 | Year | 06 | Month | 18 | Day |
2022 | Year | 06 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054763
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