UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038594 |
|---|---|
| Receipt number | R000042983 |
| Scientific Title | A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities |
| Date of disclosure of the study information | 2019/11/21 |
| Last modified on | 2022/06/13 08:00:45 |
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Basic information
Public title
A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Acronym
Pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Scientific Title
A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Scientific Title:Acronym
Pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for probability of pneumonitis in advanced non-small cell lung cancer patients with interstitial lung abnormalities treated with pembrolizumab plus platinum-based chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The probability of pneumonitis in treatment of pembrolizumab plus platinum-based chemotherapy
Key secondary outcomes
1) Objective response rate
2) Disease control rate
3) Relapse free survival
4) Severity of pneumonitis
5) Provability of pneumonitis during observation period
6) Time to occurrence of pneumonitis
7) Probability of occurrence of adverse events
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged over 20 years old
2)Advanced or postoperative recurrence non-small cell lung cancer
3)Pembrolizumab plus platinum combination chemotherapy is planned as clinical practice.
4)The proportion of linear shadows, reticular abnormalities, or ground-glass abnormalities are less than 10% of all lung fields.
5) Written informed consent is obtained.
Key exclusion criteria
1)Patients with history of drug induced pneumonitis.
2)Patients who has increased infiltration other than lung cancer within 1 month.
3)Patients with interstitial pneumonitis with UIP pattern on computed tomography.
4)Patients with interstitial pneumonitis associated with collagen diseases.
5)Pregnant women and patients who may be pregnant or breastfeeding.
6)Patients who are judged to be inappropriate for the study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
81-78-382-5661
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Katsurada |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
81-78-382-5661
Homepage URL
nk1208@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
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
Institutional Review Board, Kobe University Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
kansatsu@med.kobe-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
| 2019 | Year | 11 | 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
2
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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042983
