UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050723 |
|---|---|
| Receipt number | R000057659 |
| Scientific Title | Immune checkpoint inhibitor therapy for advanced, recurrent or metastatic non-small cell lung cancer with low or negative PD-L1 expression. |
| Date of disclosure of the study information | 2023/03/30 |
| Last modified on | 2025/08/21 17:03:13 |
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Basic information
Public title
Immune checkpoint inhibitor therapy for advanced, recurrent or metastatic non-small cell lung cancer with low or negative PD-L1 expression.
Acronym
Immune checkpoint inhibitor therapy for advanced, recurrent or metastatic non-small cell lung cancer with low or negative PD-L1 expression.
Scientific Title
Immune checkpoint inhibitor therapy for advanced, recurrent or metastatic non-small cell lung cancer with low or negative PD-L1 expression.
Scientific Title:Acronym
Immune checkpoint inhibitor therapy for advanced, recurrent or metastatic non-small cell lung cancer with low or negative PD-L1 expression.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of nivolumab plus ipilimumab (+chemotherapy) or chemotherapy with single agent immune checkpoint inhibitor in first line setting with PD-L1 low/negative expression advanced, recurrent or metastatic non-small cell lung cancer, stratified according to PD-L1 TPS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-Free Survival (PFS)
Key secondary outcomes
Progression-Free Survival Rate (12 and 24 months)
Overall survival (OS)
Survival rate (12 and 24 months)
Objective Response Rate (ORR)
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 who received nivolumab and ipilimumab (+chemotherapy) or chemotherapy with single agent immune checkpoint inhibitor in 1st line setting for advanced recurrent non-small cell lung cancer.
Definition of "advanced recurrence":
Patients with
1 Stage III not radically irradiated
2 Stage IV
3 Postoperative recurrence
4 Recurrence after radiotherapy alone
2 Patients for whom information on medical treatment and prognosis can be obtained from medical records
3 Patients over 20 years old
4 Patients with low(1-49%)/negative PD-L1 expression.
Key exclusion criteria
(i) Patients who have requested not to participate in this study based on publicly available information.
(ii) Other patients deemed ineligible by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tachihara |
| Middle name | |
| Last name | Motoko |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine/Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture, JAPAN
TEL
078-382-5660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukui |
| Middle name | |
| Last name | Takafumi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine/Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture, JAPAN
TEL
078-382-5660
Homepage URL
konkon@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOBE University Hospital Clinical Translational Reserch Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture, JAPAN
Tel
078-382-6669
chiken@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
| 2023 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
139
Results
PD-L1 TPS 1-20% group:
mOS was 12.0 months in the Single group and not reached in the Dual group (p=0.022).
mPFS was 6.9 months in the Single group and 11.5 months in the Dual group (p = 0.020).
PD-L1 TPS 21-49% population:
mOS was not reached in the Single group and 9.0 months in the Dual group (p = 0.040).
mPFS was 8.3 months in the Single group and 4.1 months in the Dual group (p = 0.087).
Results date posted
| 2025 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 139 eligible enrolled patients, 113 were in the Single group (81.3%) and 26 were in the Dual group (18.7%). The median age was 71 years (range: 43-86); 115 (82.7%) patients were male, while 24 (17.3%) were female. The ECOG-PS scores were 0 in 34 patients (24.5%), 1 in 91 patients (65.5%), 2 in 12 patients (8.6%), and 3 in two patients (1.4%). The tissue types were adenocarcinoma in 78 (56.1%), squamous cell carcinoma in 48 (34.5%), large cell carcinoma in one (0.7%), and NOS (not otherwise specified) in nine (6.5%) patients. Driver mutations were identified in 12 (8.6%), while EGFR mutations were identified in three patients (2.2%). The PD-L1 TPS was 1-20% in 94 patients (67.6%), 21-49% in 40 (27.8%). The Dual group included more patients with better ECOG-PS or driver mutations and was statistically significant. For the other factors, there were no statistically significant differences in the baseline characteristics between the Single and Dual groups. The Single group included 11 patients (9.7%) treated with the IMpower 130 regimen (atezolizumab in combination with carboplatin plus nab-paclitaxel), three (2.7%) with the IMpower 132 regimen (atezolizumab in combination with carboplatin/cisplatin plus pemetrexed), 20 (17.7%) with the IMpower 150 regimen (atezolizumab in combination with carboplatin plus paclitaxel plus bevacizumab), 43 (38.1%) with the KEYNOTE-189 regimen (pembrolizumab in combination with carboplatin/cisplatin plus pemetrexed), 34 (30.1%) with the KEYNOTE-407 regimen (pembrolizumab in combination with carboplatin plus paclitaxel/nab-paclitaxel), and two (1.8%) with the other regimens (atezolizumab in combination with carboplatin plus pemetrexed plus bevacizumab). In the Dual group, 17 patients (65.4%) were treated with the CheckMate 9LA regimen (nivolumab plus ipilimumab with chemotherapy), and nine (34.6%) with the CheckMate 227 regimen (nivolumab plus ipilimumab). The median observation period for the Single and Dual groups were 12.2 months and 12.6 months, respectively. The median duration of treatment for the Single and Dual groups was 3.9 and 3.4 months , respectively.
Participant flow
Patients who met the eligibility criteria were continuously enrolled in the study.
Adverse events
None
Outcome measures
OS was the primary endpoint, while PFS was the secondary endpoint in the population, as stratified by PD-L1 TPS in the single- and dual-therapy groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057659
