UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047001 |
|---|---|
| Receipt number | R000053621 |
| Scientific Title | Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer: individual-patient-data and study-level analyses |
| Date of disclosure of the study information | 2022/02/25 |
| Last modified on | 2024/04/03 14:22:06 |
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Basic information
Public title
Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer:
individual-patient-data and study-level analyses
Acronym
Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer:
individual-patient-data and study-level analyses
Scientific Title
Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer:
individual-patient-data and study-level analyses
Scientific Title:Acronym
Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer:
individual-patient-data and study-level analyses
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether surrogate endpoints namely objective response, disease control, PFS can surrogate OS at independent-patient- and trial-level when ICI is administered for advanced NSCLC.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to evaluate whether surrogate endpoints namely objective response, disease control, PFS can surrogate OS at independent-patient- and trial-level when ICI is administered for advanced NSCLC.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study consist of two parts: independent-patient-data analysis and trial-level analysis parts.
[Independent-patient-level analysis part]
Patients will be classified based on RECIST evaluation, CR, PR, SD, and PD. Then, overall survivals will be compared between group using hazard ratio. Correlation between PFS and OS will be also assessed.
[Study-level analysis part]
The weighted Spearman's rank correlation coefficient (r) will be used as the indicator to assess the surrogacy. The correlation with HRos will be assessed for ORorr, ORdcr, and HRpfs.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
[Independent-patient-level analysis part]
Patients should have advanced/locally-advanced/metastatic NSCLC including both squamous and non-squamous cell pathology. Specific inclusion nor exclusion criterion are not set for disease stage, PS, level of PD-L1 expression, status of EGFR mutation, ALK translocation, ROS, and RET.
[Study-level analysis part]
Study selection: We will include RCTs of any phase that medically treating the advanced/locally-advanced/metastatic NSCLC patients. Only articles written in English language will be included and conference abstracts will be excluded.
Patient selection: Patients should have advanced/locally-advanced/metastatic NSCLC including both squamous and non-squamous cell pathology. Specific inclusion nor exclusion criterion are not set for disease stage, PS, level of PD-L1 expression, status of EGFR mutation, ALK translocation, ROS, RET
Key exclusion criteria
[Independent-patient-level analysis part]
Not defined.
[Study-level analysis part]
Non-English article and conference abstract.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
+810081457872800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
+810081457872800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Yokohama City University Hospital
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
0457872800
horitano@yokohama-cu.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 | 25 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818635/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818635/
Number of participants that the trial has enrolled
3312
Results
See below:
N Horita. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses. Cancers (Basel). 2023 Jan; 15(1): 185.
Results date posted
| 2024 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See below:
N Horita. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses. Cancers (Basel). 2023 Jan; 15(1): 185.
Participant flow
See below:
N Horita. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses. Cancers (Basel). 2023 Jan; 15(1): 185.
Adverse events
See below:
N Horita. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses. Cancers (Basel). 2023 Jan; 15(1): 185.
Outcome measures
See below:
N Horita. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses. Cancers (Basel). 2023 Jan; 15(1): 185.
Plan to share IPD
IPD sharing Plan description
IPD will be provided from VIVLI
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Independent-patient-level analysis part]
RECIST-based survival will be described using Kaplan Meier curves and compared using Cox-hazard model. Patients who will be categorized to SD were used as reference.
[Study-level analysis part]
The weighted Spearman's rank correlation coefficient (r) will be used as the indicator to assess the surrogacy. The coefficient, r, will be interpreted as no (|r| < 0), weak (0.2 < |r| < 0.4), moderate (0.4 < |r| < 0.6), strong (0.6 < |r| < 0.8), or excellent (0.8 < |r|) correlation. The weighted Spearman's rank correlation was estimated using the "corr" command in the "boot" package of software "R"
Management information
Registered date
| 2022 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053621
