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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038084
Receipt No. 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 2020/03/24

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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
Condition Non-squamous Non-Small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the safety of KN 189 regimen including drug-induced pneumonitis in clinical practice in Japan.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence rate of pneumonitis within 90 days after the start of KN 189 regimen
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
Institute Kobe city medical center general hospital
Institute
Department

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
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
2019 Year 10 Month 01 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 299
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 No longer recruiting
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
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.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


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