UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040876 |
|---|---|
| Receipt number | R000046675 |
| Scientific Title | A multi-institutional, prospective, observational study of a combination of atezolizumab and chemotherapy for patients with large cell neuroendocrine carcinoma (LCNEC) of the lung (NEJ044) |
| Date of disclosure of the study information | 2020/06/24 |
| Last modified on | 2023/06/28 22:59:40 |
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Basic information
Public title
A multi-institutional, prospective, observational study of a combination of atezolizumab and chemotherapy for patients with large cell neuroendocrine carcinoma (LCNEC) of the lung (NEJ044)
Acronym
Atezolizumab and chemotherapy for LCNEC (NEJ044)
Scientific Title
A multi-institutional, prospective, observational study of a combination of atezolizumab and chemotherapy for patients with large cell neuroendocrine carcinoma (LCNEC) of the lung (NEJ044)
Scientific Title:Acronym
Atezolizumab and chemotherapy for LCNEC (NEJ044)
Region
| Japan |
Condition
Condition
Large cell neuroendocrine carcinoma (LCNEC) of the lung
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To propsectively evaluate the efficacy, safety, and biomarkers of a combination of atezolizumab and chemotherapy for patients with large cell neuroendocrine carcinoma (LCNEC) of the lung
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1-year survival rate
Key secondary outcomes
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-confirmed, advanced, metastatic, or postoperative recurrent, large cell neuroendocrine carcinoma (LCNEC) of the lung.
2. No prior systemic treatment for advanced/metastatic LCNEC. Subjects who received prior pre-operative, post-operative, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months since the last treatment.
3. Subject who is going to receive following combination therapy: (i) atezolizumab with carboplatin, paclitaxel and bevacizumab, (ii) atezoizumab with carboplatin and nab-paclitaxel, (iii) atezolizumab with carboplatin and etoposide.
4. 20 years of age or older.
5. Signed Informed Consent Form
Key exclusion criteria
1. Subjects who could not give their consent.
2. Subjects with illnesses or conditions that interfere with their capacity to understand, follow and/or comply with study procedures.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
113-8421
Address
2-2-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kztakaha@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Asao |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
113-8421
Address
2-2-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tasao@juntendo.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Institutional Review Board
Address
2-2-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
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
| 2020 | Year | 06 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-institutional, prospective, observational study
Management information
Registered date
| 2020 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046675
