UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060326 |
|---|---|
| Receipt number | R000068983 |
| Scientific Title | A multicenter study evaluating the efficacy of immune checkpoint inhibitor based combination chemotherapy according to molecular subtypes in patients with advanced or recurrent pulmonary large cell neuroendocrine carcinoma |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/01/11 14:50:03 |
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Basic information
Public title
A multicenter study evaluating the efficacy of immune checkpoint inhibitor based combination chemotherapy according to molecular subtypes in patients with advanced or recurrent pulmonary large cell neuroendocrine carcinoma
Acronym
LCNEC-ICI Study
Scientific Title
A multicenter study evaluating the efficacy of immune checkpoint inhibitor based combination chemotherapy according to molecular subtypes in patients with advanced or recurrent pulmonary large cell neuroendocrine carcinoma
Scientific Title:Acronym
LCNEC MAP Study
Region
| Japan |
Condition
Condition
advanced or recurrent pulmonary large cell neuroendocrine carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to investigate the efficacy of immune checkpoint inhibitor based combination chemotherapy and to elucidate molecular subtypes in patients diagnosed with advanced or recurrent pulmonary large cell neuroendocrine carcinoma who have received immune checkpoint inhibitor based combination chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between molecular subtypes and the efficacy of immune checkpoint inhibitor based combination chemotherapy in patients diagnosed with advanced or recurrent pulmonary large cell neuroendocrine carcinoma and to clarify progression free survival PFS in this patient population.
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. Patients with a histologically confirmed diagnosis of advanced or recurrent pulmonary large cell neuroendocrine carcinoma who received immune checkpoint inhibitor based combination systemic therapy as first line treatment.
2. Definition of advanced or recurrent disease. Patients meeting at least one of the following criteria.
Patients meeting at least one of the following criteria:
- Unresectable stage III disease not amenable to definitive radiotherapy limited to cases in which the radiation field is excessively extensive and definitive radiotherapy is not feasible. Patients for whom chemotherapy was selected due to interstitial lung disease or poor performance status are excluded.
- Stage IV disease.
- Recurrent disease.
Recurrent disease includes the following.
- Recurrence after surgical resection.
- Recurrence after definitive radiotherapy alone.
In patients who received adjuvant chemotherapy after surgery the first systemic chemotherapy administered after recurrence is defined as first line treatment.
3. Pulmonary large cell neuroendocrine carcinoma is defined as meeting all of the following criteria.
1) Morphologically classified as non small cell lung carcinoma lacking features of squamous cell carcinoma and adenocarcinoma.
2) Positive immunohistochemical staining for at least two of the following neuroendocrine markers synaptophysin chromogranin A and CD56.
4. Patients for whom information on clinical course treatment details and prognosis can be obtained from medical records.
5. Patients aged 20 years or older at the time of diagnosis.
Key exclusion criteria
1. Patients who have indicated their refusal to participate in this study based on publicly disclosed study information (opt-out).
2. Patients deemed inappropriate for inclusion in this study by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Hospital
Division name
Department of Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5668
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Okamoto |
Organization
Kobe University Hospital
Division name
Department of Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5668
Homepage URL
mokamoto@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Kobe University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6669
kansatsu@med.kobe-u.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 | 03 | Month | 01 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study of patients with advanced or recurrent pulmonary large cell neuroendocrine carcinoma and does not involve any interventional procedures. Analyses will be conducted using data obtained from medical records and existing biopsy specimens. The study will be initiated after approval by the Ethics Committee of Kobe University Hospital. Participation will be based on an opt out approach, and no external funding is involved.
Management information
Registered date
| 2026 | Year | 01 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068983
