UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062582 |
|---|---|
| Receipt number | R000071635 |
| Scientific Title | Multicenter Retrospective Observational Study Evaluating the Efficacy and Safety of Immune Checkpoint Inhibitor-Based Therapy in Patients with Unresectable Advanced Invasive Mucinous Adenocarcinoma of the lung |
| Date of disclosure of the study information | 2026/08/14 |
| Last modified on | 2026/08/14 23:16:44 |
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Basic information
Public title
Study of the Effectiveness and Safety of Drug Therapy Including Immune Checkpoint Inhibitors for Unresectable Advanced Invasive Mucinous Adenocarcinoma of the Lung
Acronym
NEJ072
Scientific Title
Multicenter Retrospective Observational Study Evaluating the Efficacy and Safety of Immune Checkpoint Inhibitor-Based Therapy in Patients with Unresectable Advanced Invasive Mucinous Adenocarcinoma of the lung
Scientific Title:Acronym
NEJ072
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent invasive mucinous adenocarcinoma of the lung
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of immune checkpoint inhibitor-based therapy in patients with unresectable advanced invasive mucinous adenocarcinoma of the lung. In particular, this study aims to evaluate the efficacy of combination therapy with cytotoxic chemotherapy and immune checkpoint inhibitors as first-line treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS) in the chemotherapy group versus the chemotherapy plus immune checkpoint inhibitor group.
Key secondary outcomes
Progression-free survival (PFS) in the chemotherapy group versus the chemotherapy plus immune checkpoint inhibitor group.
Objective response rate (ORR) in the chemotherapy group versus the chemotherapy plus immune checkpoint inhibitor group.
Time to next treatment (TTNT) in the chemotherapy group versus the chemotherapy plus immune checkpoint inhibitor group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed on or after January 1, 2011, with histopathological findings consistent with invasive mucinous adenocarcinoma (IMA) and no other more appropriate histological subtype.
2.Patients with unresectable clinical stage III or IV disease, or recurrence after surgical resection or definitive (chemo)radiotherapy. Clinical stage is classified according to the 8th edition of the UICC TNM classification.
3.Patients who initiated first-line systemic therapy between January 1, 2011 and September 30, 2025.
Key exclusion criteria
1.Patients who received neoadjuvant or adjuvant chemotherapy, or consolidation therapy after chemoradiotherapy, and initiated first-line treatment for recurrence within 6 months after the last administration of the preceding therapy.
2.Patients considered inappropriate for inclusion in the study by the investigator.
3.Patients who expressed refusal to participate in the study.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Mimori |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Respiratory Medicine
Zip code
410-2295
Address
1129 Nagaoka, Izunokuni, Shizuoka 410-2295, Japan
TEL
055-948-3111
t-mimori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Kida |
Organization
Asahikawa Medical University Hospital
Division name
Department of Respiratory Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-69-3290
Homepage URL
rkida@asahikawa-med.ac.jp
Sponsor or person
Institute
Specified Nonprofit Corporation North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Asahikawa Medical University Hospital
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
Juntendo University Faculty of Medicine Medical Research Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2026 | Year | 08 | Month | 14 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study. Patients who initiated first-line systemic therapy between January 1, 2011 and September 30, 2025 will be retrospectively identified. The clinical data cutoff date is December 31, 2025.
Management information
Registered date
| 2026 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071635
