UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041507
Receipt number R000047355
Scientific Title Database study of adverse events in atezolizumab combination with carboplatin plus paclitaxel with bevacizumab therapy in patients with previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer
Date of disclosure of the study information 2020/08/21
Last modified on 2020/08/20 16:05:54

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Basic information

Public title

Database study of adverse events in atezolizumab combination with carboplatin plus paclitaxel with bevacizumab therapy in patients with previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer

Acronym

Database study of adverse events in atezolizumab combination with carboplatin plus paclitaxel with bevacizumab therapy in patients with previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer

Scientific Title

Database study of adverse events in atezolizumab combination with carboplatin plus paclitaxel with bevacizumab therapy in patients with previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer

Scientific Title:Acronym

Database study of adverse events in atezolizumab combination with carboplatin plus paclitaxel with bevacizumab therapy in patients with previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety of atezolizumab combination with carboplatin plus paclitaxel with bevacizumab therapy using a database from DPC in patients with previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer in Japan

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence, rates, severity and time to onset of adverse events, and treatment for adverse events

Key secondary outcomes



Base

Study type

Observational


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

Patients with non-squamous non-small cell lung cancer

Key exclusion criteria

Patients who have been diagnosed with malignant tumors other than non-squamous non-small cell lung cancer and have undergone chemotherapy for non-small cell lung cancer

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Kaori
Middle name
Last name Ouchi

Organization

CHUGAI PHARMACEUTICAL CO., LTD.

Division name

Medical Affairs Div.

Zip code

103-8324

Address

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo 103-8324, Japan

TEL

0332730866

Email

cma-clinicaltrial@chugai-pharm.co.jp


Public contact

Name of contact person

1st name CHUGAI PHARMACEUTICAL
Middle name
Last name CO., LTD.

Organization

Medical Affairs Div.

Division name

Medical Science Dept.

Zip code

103-8324

Address

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo 103-8324, Japan

TEL

0332730866

Homepage URL


Email

cma-clinicaltrial@chugai-pharm.co.jp


Sponsor or person

Institute

CHUGAI PHARMACEUTICAL CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

CHUGAI PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

1-15-14, Dogenzaka, Shibuya, Tokyo, Japan

Tel

0364161868

Email

npo-mins@j-irb.com


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 08 Month 21 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


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

Preinitiation

Date of protocol fixation

2020 Year 06 Month 18 Day

Date of IRB

2020 Year 06 Month 18 Day

Anticipated trial start date

2020 Year 08 Month 24 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

A cohort study using a Japanese healthcare database


Management information

Registered date

2020 Year 08 Month 21 Day

Last modified on

2020 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name