UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060603 |
|---|---|
| Receipt number | R000069306 |
| Scientific Title | A retrospective study of the efficacy and safety of chemoimmunotherapy for extensive stage of small cell lung cancer in the elderly. |
| Date of disclosure of the study information | 2026/02/07 |
| Last modified on | 2026/02/06 15:38:47 |
* 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
A retrospective study of the efficacy and safety of chemoimmunotherapy for extensive stage of small cell lung cancer in the elderly.
Acronym
NLCTG2401
Scientific Title
A retrospective study of the efficacy and safety of chemoimmunotherapy for extensive stage of small cell lung cancer in the elderly.
Scientific Title:Acronym
NLCTG2401
Region
| Japan |
Condition
Condition
extensive stage of small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the IMpower133 and CASPIAN trials, the combination of a PD-L1 inhibitor and platinum-based chemotherapy demonstrated a significant survival benefit in patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). The aim of this study is to evaluate the efficacy and safety of PD-L1 inhibitor plus platinum-based chemotherapy in elderly patients aged 75 years or older with ES-SCLC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Comparison of overall survival between PD-L1 inhibitor plus platinum-based chemotherapy and platinum-based chemotherapy alone in patients aged 75 years or older with extensive-stage small-cell lung cancer.
Key secondary outcomes
Secondary endpoints: Progression-free survival, overall survival, safety (incidence of adverse events and treatment-related deaths), objective response rate, number of maintenance PD-L1 inhibitor administrations, duration of treatment success, association between immune-related adverse events (irAEs) and treatment efficacy, and association between concomitant use of proton pump inhibitors (PPIs), potassium-competitive acid blockers (P-CABs), antibiotics, probiotics, or antihistamines and treatment efficacy.
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
From August 22, 2019 to April 30, 2024, patients who meet eligibility criterion (1) or (2) below and do not meet any of the exclusion criteria will be included.
Eligibility criteria:
(1) Patients with extensive-stage small-cell lung cancer diagnosed as small-cell lung cancer by histology or cytology, or patients with combined-type lung cancer who were treated as having extensive-stage small-cell lung cancer.
(2) Patients diagnosed with extensive-stage small-cell lung cancer who did not receive systemic chemotherapy and were managed with best supportive care alone.
Key exclusion criteria
(1) Patients with limited-stage small-cell lung cancer who underwent surgery, definitive radiotherapy, or chemotherapy.
(2) Patients enrolled in interventional studies (those enrolled only in observational studies are eligible).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-757 Asahimachidori, Chuouku, Niigata
TEL
+81-25-368-9325
satoshi7@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Kobayashi |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-757 Asahimachidori, Chuouku, Niigata
TEL
08012361399
Homepage URL
kobami733.45hh@niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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 for Human Research, Niigata University
Address
1-757 Asahimachidori, Chuouku, Niigata
Tel
025-227-2625
ethics@adm.niigata-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 | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://conference.haigan.gr.jp/66/
Number of participants that the trial has enrolled
343
Results
A total of 343 patients were included in the analysis. Of these, 218 received PD-L1 inhibitor-combined chemotherapy, and 65 of these patients were aged 75 years or older. In the PD-L1 inhibitor-combined group, the median OS was 13.6 and 15.0 months, respectively (p=0.7320). Grade 3 or higher non-irAEs occurred in 47 patients aged 75 years or older and 103 patients aged 74 years or younger (p=0.5247), while irAEs occurred in 4 and 12 patients, respectively (p=0.7823).
Results date posted
| 2026 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 06 | Day |
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
| 2024 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background: This study aimed to clarify the efficacy and safety of PD-L1 inhibitor plus platinum-based chemotherapy in elderly patients aged 75 years or older with extensive-stage small cell lung cancer (ES-SCLC).
Methods: We retrospectively analyzed patients diagnosed with and treated for ES-SCLC within the Niigata Lung Cancer Treatment Study Group from August 22, 2019, to April 30, 2024.
Results: A total of 364 patients were enrolled; after excluding 21 patients due to prior treatment or ineligible histology, 343 patients were included in the analysis. Among them, 218 patients received PD-L1 inhibitor-combined chemotherapy, of whom 65 were aged 75 years or older. In the chemotherapy-alone group, 67 patients were aged 75 years or older. In the PD-L1 inhibitor-combined group, the median progression-free survival (PFS) was 4.9 months in patients aged 75 years or older versus 4.8 months in those aged less than 75 years (p=0.7611), and the median overall survival (OS) was 13.6 months versus 15.0 months, respectively (p=0.7320). Grade 3 or higher non-immune-related adverse events occurred in 47 versus 103 patients (p=0.5247), and immune-related adverse events occurred in 4 versus 12 patients (p=0.7823) in the 75-years-or-older and less-than-75-years subgroups, respectively.
Conclusion: In patients aged 75 years or older with ES-SCLC, the addition of a PD-L1 inhibitor to platinum-based chemotherapy prolonged OS, and PFS and OS were not significantly different compared with patients younger than 75 years. The incidence of grade 3 or higher adverse events also did not differ according to age.
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069306
