UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046700 |
|---|---|
| Receipt number | R000053211 |
| Scientific Title | Real-world data of immunotherapy in combination with chemotherapy in elderly patients with previously untreated advanced non-small-cell lung cancer: A multicenter retrospective study (NEJ057) |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/06/28 09:49:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Real-world data of immunotherapy in combination with chemotherapy in elderly patients with previously untreated advanced non-small-cell lung cancer: A multicenter retrospective study (NEJ057)
Acronym
Real-world data of immunotherapy in combination with chemotherapy in elderly patients with previously untreated advanced non-small-cell lung cancer: A multicenter retrospective study (NEJ057)
Scientific Title
Real-world data of immunotherapy in combination with chemotherapy in elderly patients with previously untreated advanced non-small-cell lung cancer: A multicenter retrospective study (NEJ057)
Scientific Title:Acronym
NEJ057
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the first-line treatment selection in elderly patients with advanced non-small cell lung cancer, and to clarify the efficacy and safety of immunotherapy in combination with chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival
Time-to-treatment-failure
Response rate
Safety
Regimens selected as initial treatment
Prognostic factors
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Cytologically or histologically confirmed non-small cell lung cancer
2 Clinical stage IIIB, IIIC without indication of definitive thoracic radiotherapy, stage IV, postoperative or radiotherapy recurrent disease
3 Patients who started first-line systemic therapy between December 2018 and March 2021
4 Patients who were over 75 years old at the initiation of first-line systemic therapy
Key exclusion criteria
1 Patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangement
2 Patients whose attending doctor consider as inappropriate for this study
3 Patients whose first-line systemic therapy was molecular-targeted therapy
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-8539
miyauchi@rm.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Tsukita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-8539
Homepage URL
y-tsukita@rm.med.tohoku.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1245
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
Main results already published
Date of protocol fixation
| 2021 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter retrospective study
Management information
Registered date
| 2022 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | 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=R000053211
