UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049936 |
|---|---|
| Receipt number | R000056873 |
| Scientific Title | Efficacy and Safety of Nivolumab+Ipilimumab or Pembrolizumab for Patients with Untreated Advanced or Recurrent Non-small Cell Lung Cancer; A Multicenter Retrospective Observational Study |
| Date of disclosure of the study information | 2022/12/29 |
| Last modified on | 2025/04/28 10:00:52 |
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Basic information
Public title
Efficacy and Safety of Nivolumab+Ipilimumab or Pembrolizumab for Patients with Untreated Advanced or Recurrent Non-small Cell Lung Cancer; A Multicenter Retrospective Observational Study
Acronym
Efficacy and Safety of Nivolumab+Ipilimumab or Pembrolizumab for Patients with Untreated Advanced or Recurrent Non-small Cell Lung Cancer; A Multicenter Retrospective Observational Study
Scientific Title
Efficacy and Safety of Nivolumab+Ipilimumab or Pembrolizumab for Patients with Untreated Advanced or Recurrent Non-small Cell Lung Cancer; A Multicenter Retrospective Observational Study
Scientific Title:Acronym
Efficacy and Safety of Nivolumab+Ipilimumab or Pembrolizumab for Patients with Untreated Advanced or Recurrent Non-small Cell Lung Cancer; A Multicenter Retrospective Observational Study
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 efficacy and safety, and those risk factors of CM227 and CM9LA regimens as first-line therapy for patients with advanced or recurrent non-small cell lung cancer. To compare to those of KN189 regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy (objective response rate, progression-free survival,and overall survival) and safety (adverse events, serious adverse events,and treatment-related death) of CM227 and CM9LA regimens
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with non-small cell lung cancer who have clinical stage III, IV or relapsed after radical treatment with surgery or radiotherapy according to the TNM classification, 8th edition
2) Patients who started CM227 or CM9LA or KN189 regimens as first-line therapy between December 1, 2018 and May 31, 2022
Key exclusion criteria
Nothing
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Shiroyama |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3831
shiroyamat@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kinnosuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3831
Homepage URL
m.kinnosuke@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Osaka University
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
Graduate School of Medicine, Osaka University
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
565-0871
m.kinnosuke@gmail.com
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 | 12 | Month | 29 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00262-023-03583-4
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00262-023-03583-4
Number of participants that the trial has enrolled
600
Results
The median TTD was 6.2 and 5.1 months (hazard ratio (HR): 0.88, 95% confidence interval (CI): 0.65-1.18, P = 0.394)) and the median PFS was 11.6 and 7.4 months (HR: 0.91, 95%CI: 0.66-1.27, P = 0.582) in the NICT and PCT groups, respectively. Moreover, the median OS was significantly longer in the NICT group than in the PCT group (26.0 vs. 16.8 months, HR: 0.54, 95%CI: 0.35-0.83, P = 0.005).
Results date posted
| 2025 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive patients with histologically confirmed advanced or recurrent-stage NSCLC were registered through the electronic databases of 14 institutes in Japan: those who were treated with a first-line combination of nivolumab plus ipilimumab or pembrolizumab with platinum-based chemotherapy were included, and those with major EGFR gene mutation (exon 21 L858R or exon 19 deletion) mutations and ALK/ROS1 rearrangements were excluded. Patients for whom treatment was initiated between December 2018 and May 2022 were included, and the cutoff date for data collection was May 31, 2023.
Participant flow
Consecutive patients with histologically confirmed advanced or recurrent-stage NSCLC were registered through the electronic databases of 14 institutes in Japan: those who were treated with a first-line combination of nivolumab plus ipilimumab or pembrolizumab with platinum-based chemotherapy were included, and those with major EGFR gene mutation (exon 21 L858R or exon 19 deletion) mutations and ALK/ROS1 rearrangements were excluded. Patients for whom treatment was initiated between December 2018 and May 2022 were included, and the cutoff date for data collection was May 31, 2023.
Adverse events
In total, 28 (34.6%) and 50 (30.9%) patients in the NICT and PCT groups, respectively, experienced grade3 or higher SAEs (P = 0.560), and 15 (18.5%) and 31 (19.1%) patients discontinued treatment owing to SAEs, respectively (P = 0.908). Two (2.5%) and six (3.7%) patients died from treatment-related AEs (P = 0.722): one of pneumonitis and one of steroid-related infection in the NICT group and four of pneumonitis and two of colitis in the PCT group. Among the patients who developed SAEs, the most frequent event was pneumonitis (8.6% of patients); however, no significant difference was noted between the NICT and PCT groups (P = 0.333). Among all SAEs, skin and hepatobiliary toxicities and adrenal pituitary disorder occurred more frequently in the NICT group than in the PCT group, although the difference was not significant.
Outcome measures
Clinical responses were defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Time to treatment discontinuation (TTD) was defined as the period from the first-line treatment start date to the date of discontinuation for any cause. Progression-free survival (PFS) was defined as the period from the first-line treatment start date to the date of disease progression or death from any cause, and OS was determined from the first-line treatment start date to the date of death or last follow-up. The safety level was evaluated using the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE, ver5) based on AE incidence, treatment discontinuation, and treatment-related death (TRD). In this study, severe AEs (SAEs) were defined as AEs or higher grade 3.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056873
