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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023853
Receipt No. 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 2018/03/04

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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
Last name of lead principal investigator
1st name
Middle name
Last name Kumanogou Atsushi
Organization Osaka University, Graduate school of Medicine
Division name Dept. of Respiratory medicine, Allergy and Rheumatic Disease
Zip code
Address 2-2 Yamada-oka, Suita-city, Osaka, Japan
TEL 06-6879-5111
Email kumanogo@imed3.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomonori Hirashima
Organization Osaka Habikino Medical Center
Division name Thoracic Oncology
Zip code
Address 3-7-1 Habikino. Habikino city, Osaka
TEL 072-957-2121
Homepage URL
Email hirashimat@ra.opho.jp

Sponsor
Institute Osaka University, Graduate school of Medicine, Respiratory medicine, Allergy and Rheumatic Disease
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2018 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027483

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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