UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041916 |
|---|---|
| Receipt number | R000047842 |
| Scientific Title | Pneumonitis in the combination therapy of immune checkpoint inhibitors and chemotherapy: a meta-analysis of phase 3 randomized clinical trials |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2021/12/20 12:37:15 |
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Basic information
Public title
Pneumonitis in the combination therapy of immune checkpoint inhibitors and chemotherapy: a meta-analysis of phase 3 randomized clinical trials
Acronym
Not applicable due to meta-analysis
Scientific Title
Pneumonitis in the combination therapy of immune checkpoint inhibitors and chemotherapy: a meta-analysis of phase 3 randomized clinical trials
Scientific Title:Acronym
Pneumonitis in the combination therapy with immune checkpoint inhibitors: Insights from a meta-analysis
Region
| Japan | North America |
Condition
Condition
Solid tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this meta-analysis is to report the incidence and degree of pneumonitis by a specific type of immune checkpoint inhibitor (ICI) including PD-1 inhibitor, PD-L1 inhibitor, and CTLA-4 inhibitor when combined with other systemic chemotherapy such as cytotoxic chemotherapy and molecular-targeting therapy for solid tumors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary objective is to compare the incidence of pneumonitis induced by adding immune checkpoint inhibitors to other therapy and to analyze the contribution of a specific type of immune checkpoint inhibitors to the AE. The total number of participants is used as a denominator when calculating the incidence of pneumonitis.
Key secondary outcomes
The following outcomes will be defined: occurrence of all grades pneumonitis events and the occurrence of grade 3 and more pneumonitis events.
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
(1) The published study designed as a randomized clinical trial (RCT).
(2) The experimental group of the study was treated with at least one type of ICIs with or without other systemic chemotherapy and the control group of the study was treated with systemic chemotherapy including cytotoxic chemotherapy, ICI, and molecular-targeting therapy, ICI-placebo, or best supportive care (BSC).
(3) The study with three arms where ICI is included at least one arm.
(4) The patients were clinically diagnosed with any solid tumor.
(5) The study illustrates the outcome of pneumonitis, all adverse events (AEs), and grade 3-5 AEs.
(6) Only full-text papers are used to analyze.
Key exclusion criteria
(1) Systematic review or meta-analysis articles.
(2) Retrospective analysis.
(3) Single prospective cohort study without a control group.
(4) Non-RCT.
(5) The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria.
(6) Studies with no or insufficient safety results at the time of the literature search.
(7) Studies published in languages other than English.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Fujiwara |
Organization
Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel
Division name
Department of Medicine
Zip code
10003
Address
281 1st Avenue New York, NY, USA
TEL
1-212-420-2000
yu.fujiwara@mountsinai.org
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Fujiwara |
Organization
Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel
Division name
Department of Medicine
Zip code
10003
Address
281 1st Avenue New York, NY, USA
TEL
1-212-420-2000
Homepage URL
yu.fujiwara@mountsinai.org
Sponsor or person
Institute
Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel
Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Not applicable
Address
Not applicable
Tel
1-212-420-2000
yu.fujiwara@mountsinai.org
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 | 28 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047842
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33906099/
Number of participants that the trial has enrolled
15006
Results
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Results date posted
| 2021 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Date of the first journal publication of results
Baseline Characteristics
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Participant flow
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Adverse events
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Outcome measures
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Plan to share IPD
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
IPD sharing Plan description
Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012.
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PubMed/MEDLINE, Web of Science, Embase, and Cochrane Library will be used. The search terms are as follows.
#1 (Atezolizumab) OR (Avelumab) OR (Cemiplimab) OR (Durvalumab) OR (Ipilimumab) OR (Nivolumab) OR (Pembrolizumab) OR (Tremelimumab) OR (Immune checkpoint inhibitor) OR (Tecentriq) OR (Bavencio) OR (Libtayo) OR (Imfinzi) OR (Yervoy) OR (Opdivo) OR (Keytruda) OR (Spartalizumab) OR (Immune checkpoint inhibitor) OR (MPDL3280A) OR (RG7446) OR (MSB0010718C) OR (REGN2810) OR (MEDI4736) OR (BMS-734016) OR (MDX-010) OR (MDX-101) OR (ONO-4538) OR (BMS-936558) OR (MDX1106) OR (MK-3475) OR (lambrolizumab) OR (CP-675,206) OR (Ticilimumab) OR (PDR001)
#2 (Randomized) OR (Randomised) OR (RCT) OR (Randomly)
#3 (phase III) OR (phase 3) OR (phaseIII) OR (phase3) OR (phase-III) OR (phase-3) OR (P3)
#4 #1 AND #2 AND #3
Data will be extracted from eligible studies by two different investigators and disagreements will be resolved by consensus from a third investigator. Following information will be extracted: First author, publication year, journal, sample size in each group, type of cancer, type of ICI, type of systemic treatment, placebo use, details of chemotherapy, setting of treatment (early-stage or advanced, unresectable, or metastatic disease), incidence and severity of pneumonitis and all adverse events. The Cochrane risk of bias assessment tool will be used. Odds ratio will be calculated. Funnel plots will be used for the publication bias. Significance will be set for equivalence hypothesis testing using the two-tailed 0.05 level. The two-tailed 0.10 level will be used to set the significance for statistical heterogeneity. We will use the R software. Subgroups analyses will be done for the type of systemic therapy with immune checkpoint inhibitors such as the type of cytotoxic chemotherapy and molecular-targeting therapy, and each cancer type to assess their contribution to pneumonitis.
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047842
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