UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000038084
Receipt number	R000043318
Scientific Title	The safety SUrvey of pneumonitis induced by the combination of platinum, pemetrexed and pembrolizumab in chemo-naive non-small cell lung cancer patient in the real-world setting.
Date of disclosure of the study information	2019/10/01
Last modified on	2023/09/26 10:04:22

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Basic information

Public title

The safety SUrvey of pneumonitis induced by the combination of platinum, pemetrexed and pembrolizumab in chemo-naive non-small cell lung cancer patient in the real-world setting.

Acronym

SUSPECT study

Scientific Title

The safety SUrvey of pneumonitis induced by the combination of platinum, pemetrexed and pembrolizumab in chemo-naive non-small cell lung cancer patient in the real-world setting.

Scientific Title:Acronym

SUSPECT study

Region

Japan

Condition

Non-squamous Non-Small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To examine the safety of KN 189 regimen including drug-induced pneumonitis in clinical practice in Japan.
If the frequency is above a certain level, treatment for pneumonitis and prognostic factors will be investigated through central imaging.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

co-primary
The incidence rate of pneumonitis within 90 days after the start of KN 189 regimen
If the frequency is above a certain level, treatment for pneumonitis and prognostic factors will be investigated through central imaging.

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

20 years-old <=

Age-upper limit

120 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Advanced non-squamous non-cell lung cancer patients (relapsed or stage III, IV)
2)Patients without mutated EGFR and ALK translocation.
3)Patients who received platinum / pemetrexed / pembrolizumab combination therapy as 1st-line treatment between 2018/12/21 and 2019/6/30.

Key exclusion criteria

Nothing

Target sample size

300

Research contact person

Name of lead principal investigator

1st name Satoru

Middle name

Last name Miura

Organization

Niigata Cancer Center Hospital

Division name

Department of Internal Medicine

Zip code

951-8566

Address

2-15-3, Kawagishicho, Chuo-ku, Niigata

TEL

025-266-5111

Email

miusat1118@niigata-cc.jp

Public contact

Name of contact person

1st name Daichi

Middle name

Last name Fujimoto

Organization

Kobe city medical center general hospital

Division name

Division of pulmonary medicine

Zip code

650-0047

Address

2-1-1, minatojima-minamimachi, chuo-ku, Kobe

TEL

078-302-4321

Homepage URL

Email

daichianzen@yahoo.co.jp

Sponsor or person

Institute

Kobe city medical center general hospital

Institute

Department

Personal name

Funding Source

Organization

Kobe city medical center general hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Kobe city medical center general hospital

Address

2-1-1, minatojima-minamimachi, chuo-ku, Kobe

Tel

078-302-4321

Email

daichianzen@yahoo.co.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 01 Day

Related information

URL releasing protocol

N/A

Publication of results

Published

Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/36878936/

Number of participants that the trial has enrolled

299

Results

Radiographic features at diagnosis predominantly comprised an organizing pneumonia pattern. Twelve patients experienced a worsening respiratory status during pneumonitis management, which was associated with a high mortality rate during treatment. Severe grade at pneumonitis diagnosis, diffuse alveolar damage (DAD) pattern, and disease extent in the lungs were significantly associated with worsening respiratory status.

Results date posted

2023 Year 09 Month 26 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

described in the paper

Participant flow

retrospective study

Adverse events

Discribed in the paper

Outcome measures

Discribed in the paper

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 08 Month 22 Day

Date of IRB

1984 Year 08 Month 24 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

retrospective cohort study

Management information

Registered date

2019 Year 09 Month 23 Day

Last modified on

2023 Year 09 Month 26 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043318

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name