UMIN-CTR Clinical Trial

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
Email	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
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	Osaka Habikino Medical Center
Address	3-7-1 Habikino Habikino City, Osaka
Tel	0729572121
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027483