UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000041916 |
| Receipt No. | 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 (Ver. 7) |
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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 | ||
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| Condition | ||
| Condition | Solid tumors | |
| Classification by specialty |
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| 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 | |
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| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
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| Interventions/Control_3 | |
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| Interventions/Control_5 | |
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| Interventions/Control_7 | |
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| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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. |
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| 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. |
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| Target sample size | 30000 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel
Department of Medicine |
| Institute | |
| Department | |
| 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 | |
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| IND to MHLW | |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012. |
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| 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. |
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| Participant flow | Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012. |
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| Adverse events | Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012. |
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| Outcome measures | Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012. |
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| Plan to share IPD | Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012. |
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| IPD sharing Plan description | Please see:
Eur J Cancer. 2021 Jun;150:168-178. doi: 10.1016/j.ejca.2021.03.012. |
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| Progress | |||||||
| Recruitment status | Main results already published | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| 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. |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047842 |
