UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044937 |
|---|---|
| Receipt number | R000051328 |
| Scientific Title | The clinical effects of immune checkpoint inhibitors combined with anti-angiogenic agents for advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2021/07/21 |
| Last modified on | 2022/12/28 12:38:08 |
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Basic information
Public title
The clinical effects of immune checkpoint inhibitors combined with anti-angiogenic agents for advanced non-small cell lung cancer
Acronym
The clinical effects of immune checkpoint inhibitors combined with anti-angiogenic agents for advanced non-small cell lung cancer
Scientific Title
The clinical effects of immune checkpoint inhibitors combined with anti-angiogenic agents for advanced non-small cell lung cancer
Scientific Title:Acronym
The clinical effects of immune checkpoint inhibitors combined with anti-angiogenic agents for advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical effect of immune checkpoint inhibitors combined with anti-angiogenic agents
Basic objectives2
Others
Basic objectives -Others
To evaluate the differences in effectiveness depending on the timing and order of administration of concomitant drugs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endopoint are overall survival, progression-free survival,and overall response rate.
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
NSCLC patients who received immune checkpoint inhibitors and anti-angiogenic agents combination therapy or either monotherapy
Key exclusion criteria
Patients without data about survival or tumor response
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kinnosuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
565-0871
Address
Yamadaoka, Suita
TEL
+810668793831
m.kinnosuke@gmail.com
Public contact
Name of contact person
| 1st name | Kinnosuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
565-0871
Address
Yamadaoka, Suita
TEL
+810668793831
Homepage URL
m.kinnosuke@gmail.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
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
None
Address
None
Tel
None
None
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
| 2021 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=268286
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0169500221006012
Number of participants that the trial has enrolled
2414
Results
ICI and AA therapy had significantly higher ORR than either monotherapy. PFS and OS were favorable benefits in ICI and AA therapy; however, significant heterogeneity was identified in these analyses. According to the administration timing and sequence, ICI immediately after AA showed no PFS and OS benefits compared to ICI monotherapy, whereas favorable PFS and OS were demonstrated when AA was concomitantly administered with ICI or when AA was administered immediately after ICI.
Results date posted
| 2022 | Year | 12 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were as follows: (I) observational studies or randomized controlled trials involving NSCLC patients who received both ICI and AA concomitantly or sequentially with or without cytotoxic chemotherapies (e.g. atezolizumab + bevacizumab + carboplatin + paclitaxel, bevacizumab + cisplatin + pemtrexed to nivolumab, pembrolizumab to ramucirumab + docetaxel); (II) comparative studies of concomitant or sequential ICI and AA therapy versus either monotherapy (Fig. 1); (III) studies with data on response rate or survival data or both; and (IV) articles written in English. We excluded reviews, case reports, animal studies, or duplicate publications.
Participant flow
The study protocol was registered in the International Prospective Register of Systematic Reviews CRD 42021268286. Our systematic review and meta-analysis followed PRISMA guidelines. Some databases, including PubMed-MEDLINE, Embase-Scopus, and Web of Science were searched for eligible studies published before August 23, 2021.
Adverse events
Not evaluated.
Outcome measures
The primary endpoint was the efficacy of ICI and AA therapy compared to ICI or AA monotherapy, including the odds ratio (OR) for ORR and the HR for PFS and OS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 08 | Month | 20 | Day |
Other
Other related information
Study Search
Studies will be systematically searched through PubMed-MEDLINE and EMBASE-Scopus, as of July 21, 2021.
The search strategy will be as follows:
# non-small cell lung cancer
AND
# immune checkpoint inhibitor
AND
# anti-angiogenic agents
should be included.
Data synthesis
From the data obtained, the efficacy of immune checkpoint inhibitors and anti-angiogenic agents will be compared to the monotherapy.
Statistical significance will be judged by P < 0.05.
Management information
Registered date
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051328
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