UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041702 |
|---|---|
| Receipt number | R000047602 |
| Scientific Title | Comparative Efficacy and Safety of Immunotherapeutic Regimens with PD-1/PD-L1 Inhibitors for Pre-viously Untreated Extensive-Stage Small-Cell Lung Cancer: A Systematic Review and Network Me-ta-analysis |
| Date of disclosure of the study information | 2020/09/07 |
| Last modified on | 2021/01/08 10:26:13 |
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Basic information
Public title
Comparative Efficacy and Safety of Immunotherapeutic Regimens with PD-1/PD-L1 Inhibitors for Pre-viously Untreated Extensive-Stage Small-Cell Lung Cancer: A Systematic Review and Network Me-ta-analysis
Acronym
Immunotherapeutic Regimens with PD-1/PD-L1 Inhibitors for Pre-viously Untreated Extensive-Stage Small-Cell Lung Cancer
Scientific Title
Comparative Efficacy and Safety of Immunotherapeutic Regimens with PD-1/PD-L1 Inhibitors for Pre-viously Untreated Extensive-Stage Small-Cell Lung Cancer: A Systematic Review and Network Me-ta-analysis
Scientific Title:Acronym
Immunotherapeutic Regimens with PD-1/PD-L1 Inhibitors for Pre-viously Untreated Extensive-Stage Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Extensive stage small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of immune checkpoint inhibitors and platinum-irinotecan combination therapy for extensive stage small cell lung cancer, and to compare the ICI-containing immunotherapeutic regimens with each other.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression free survival
Incidence of Grade 3 or higher any adverse events
Incidence of Grade 3 or higher neutropenia, anemia, and thrombocytopenia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cytologically or histologically confirmed advanced small cell lung cancer.
Performance status 0 to 2
Not received previous systemic anti-cancer treatment.
Key exclusion criteria
non-small cell lung cancer patients
Poor performance status (3 or more)
Patients previously treated with systemic anticancer therapy
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa University
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-3784-8532
koichi-a@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-3784-8532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
Tel
+81-3-3784-8532
koichi-a@med.showa-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
| 2020 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
3879
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aimed to perform a network meta-analysis of relevant phase 3 trials to compare and rank the six treatment arms of pembrolizumab added on platinum plus etoposide, durvalumab added on platinum plus etoposide, atezolizumab added on platinum plus etoposide, platinum plus amrubicin, platinum plus irinotecan, and platinum plus etoposide using a Bayesian approach. The primary efficacy and safety endpoints were overall survival and incidence of grade 3 or more of adverse events, respectively. The surface under the cumulative ranking curve values for efficacy and safety outcomes were assessed to rank each treatment group. No significant differences in overall survival were observed between the pembrolizumab added on platinum plus etoposide and platinum plus irinotecan; durvalumab added on platinum plus etoposide and platinum plus irinotecan; and atezolizumab added on platinum plus etoposide and platinum plus irinotecan groups. Overall survival was the highest for atezolizumab added on platinum plus etoposide, followed by durvalumab added on platinum plus etoposide, pembrolizumab added on platinum plus etoposide, platinum plus irinotecan, platinum plus amrubicin, and platinum plus etoposide. The incidence of grade 3 or more of adverse events was significantly higher in the pembrolizumab added on platinum plus etoposide and atezolizumab added on platinum plus etoposide groups than in the platinum plus irinotecan group. The surface under the cumulative ranking curve values for grade 3 or more of adverse events indicated that IP was the safest, followed by durvalumab added on platinum plus etoposide, platinum plus etoposide, atezolizumab added on platinum plus etoposide, and pembrolizumab added on platinum plus etoposide. These findings provide important insights for clinicians to better select treatment strategies for extensive-stage small-cell lung cancer.
Management information
Registered date
| 2020 | Year | 09 | Month | 06 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047602
