UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023853 |
|---|---|
| Receipt number | R000027483 |
| Scientific Title | Exploratory study of immunologic factors in re-biopsy specimen, peritumoral bronchoalveolar lavage fluid (BALF), and the peripheral blood for predicting response to the third generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) Osimertinib on non-small cell lung cancer patients with resistance to the first generation or the second generation EGFR-TKI |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2019/09/03 20:23:47 |
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Basic information
Public title
Exploratory study of immunologic factors in re-biopsy specimen, peritumoral bronchoalveolar lavage fluid (BALF), and the peripheral blood for predicting response to the third generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) Osimertinib on non-small cell lung cancer patients with resistance to the first generation or the second generation EGFR-TKI
Acronym
Study of immunologic factor in re-biopsy specimen, peritumoral BALF, and the peripheral blood for predicting response to Osimertinib on NSCLC patients
Scientific Title
Exploratory study of immunologic factors in re-biopsy specimen, peritumoral bronchoalveolar lavage fluid (BALF), and the peripheral blood for predicting response to the third generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) Osimertinib on non-small cell lung cancer patients with resistance to the first generation or the second generation EGFR-TKI
Scientific Title:Acronym
Study of immunologic factor in re-biopsy specimen, peritumoral BALF, and the peripheral blood for predicting response to Osimertinib on NSCLC patients
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine immunologic factors in re-biopsy specimen, peritumoral BALF, and the peripheral blood that can predict the response of Osimertinib in NSCLC patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between response to Osimertinib and a lymphocyte profile in serum, plasma or BALF, and the gene profile in tumor specimen
Key secondary outcomes
The relationship between response to anti-cancer agent except Osimertinib and a lymphocyte profile in serum, plasma or BALF, and the gene profile in tumor specimen
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
1 Patient with histologically or cytologic
ally proven NSCLC
2 EGFR mutation including exon 19 deletion
or L858R
3 Resistance to 1st or 2nd generation EGFR
-TKI
4 Under consideration of Osmertinib treatment
5 Measurable lesion
6 Performance Status (ECOG scale) 0-2
7 Good main organ functions
8 Written informed consent
Key exclusion criteria
1 Drug induced pneumonitis or lung fibrosis
2 Past interstitial pneumonitis
3 Synchronous or metachronous cancer
4 Inappropriate patient
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kumanogou |
Organization
Osaka University, Graduate school of Medicine
Division name
Dept. of Respiratory medicine, Allergy and Rheumatic Disease
Zip code
565-0871
Address
2-2 Yamada-oka, Suita-city, Osaka, Japan
TEL
06-6879-5111
kumanogo@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Hirashima |
Organization
Osaka Habikino Medical Center
Division name
Thoracic Oncology
Zip code
583-8588
Address
3-7-1 Habikino. Habikino city, Osaka
TEL
072-957-2121
Homepage URL
hirashimat@ra.opho.jp
Sponsor or person
Institute
Osaka University, Graduate school of Medicine, Respiratory medicine, Allergy and Rheumatic Disease
Institute
Department
Personal name
Funding Source
Organization
Osaka Habikino Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Habikino Medical Center
Address
3-7-1 Habikino Habikino City, Osaka
Tel
0729572121
takatsur@opho.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
| 2016 | Year | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At appropriate time, collocting specimens were analysed at Osaka University, Graduate school of Medicine, Dept. of Respiratory medicine, Allergy and Rheumatic Disease.
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027483
