UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058332 |
|---|---|
| Receipt number | R000066662 |
| Scientific Title | Efficacy of Immune Checkpoint Inhibitor Combination Chemotherapy in Patients with Recurrent NSCLC After Durvalumab Consolidation Following Chemoradiotherapy: A Multicenter Retrospective Study |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/01 12:55:38 |
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Basic information
Public title
Efficacy of Immune Checkpoint Inhibitor Combination Chemotherapy in Patients with Recurrent NSCLC After Durvalumab Consolidation Following Chemoradiotherapy: A Multicenter Retrospective Study
Acronym
NEJ066 study
Scientific Title
Efficacy of Immune Checkpoint Inhibitor Combination Chemotherapy in Patients with Recurrent NSCLC After Durvalumab Consolidation Following Chemoradiotherapy: A Multicenter Retrospective Study
Scientific Title:Acronym
NEJ066 study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the efficacy and safety of platinum-doublet chemotherapy plus immune checkpoint inhibitors versus platinum-doublet chemotherapy alone in patients with recurrent non-small cell lung cancer after chemoradiotherapy and durvalumab consolidation.
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, Objective response rate, Adverse events
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 with non-small cell lung cancer based on histological or cytological examination.
2. Among patients who received durvalumab as consolidation therapy following chemoradiotherapy, those who either: completed 1 year of durvalumab treatment,or discontinued consolidation therapy for reasons other than disease progression.
3. Patients who, between August 1, 2018 and March 31, 2023, received a platinum-doublet regimen as first-line therapy after recurrence at participating research institutions.
The use of immune checkpoint inhibitors [PD-1 inhibitors / PD-L1 inhibitors with or without CTLA-4 inhibitors], anti-VEGF agents, or anti-EGFR monoclonal antibodies in combination is permitted.Patients who underwent prior local treatment for metastatic lesions [e.g., brain or bone metastases] before first-line therapy after recurrence may also be included.
Key exclusion criteria
1. Patients positive for EGFR, ALK, ROS1, or RET gene mutations.
2. Patients who showed disease progression on the first systemic evaluation performed after completion or discontinuation of durvalumab consolidation therapy.
3. Patients who have expressed a refusal to participate in this study.
4. Patients deemed unsuitable for participation in this study by the principal investigator or sub-investigators.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Seike |
Organization
Nippon Medical School Hospital
Division name
Department of Pulmonary Medicine and Oncology
Zip code
1138603
Address
Sendagi 1-1-5 Bunkyo-ku, Tokyo
TEL
0338222131
mseike@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Iso |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Thoracic Medical Oncology
Zip code
135 8550
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
0335200111
Homepage URL
hirokazu.iso@jfcr.or.jp
Sponsor or person
Institute
Specified Nonprofit Corporation North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
Specified Nonprofit Corporation North East Japan Study Group
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
Central Ethics Comittee of the Nippon Medical School
Address
Sendagi 1-1-5 Bunkyo-ku, Tokyo
Tel
0338222131
chuorinri.group@nms.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
| 2025 | Year | 07 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Retrospective Observational Study
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066662
