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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name