UMIN-CTR Clinical Trial

Basic information
Public title	Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Acronym	Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Scientific Title	Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Scientific Title:Acronym	Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Region	Japan

Condition
Condition	EGFR mutated non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore clinical factors that may be candidates for determining susceptibility to osimertinib in EGFR mutated NSCLC patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between treatment response with osimertinib treatment and patients background
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with evaluable disease by RECIST (version 1.1) before osimertinib administration 2) NSCLC patients with EGFR active mutation 3) Patients with formalin-fixed, paraffin-embedded blocks that do not interfere with pathological diagnosis and for whom consent for their use can be obtained from the patient.
Key exclusion criteria	Patients judged as inappropriate by the physician in charge
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tadaaki Middle name Last name Yamada
Organization	Kyoto Prefectural University of Medicine
Division name	Pulmonary Medicine
Zip code	6028566
Address	465, Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5513
Email	tayamada@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Yoshimura
Organization	Kyoto Prefectural University of Medicine
Division name	Pulmonary Medicine
Zip code	6028566
Address	465, Kajii-cho, Kamigyo-ku, Kyoto
TEL	0752515513
Homepage URL
Email	aki-y@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1. Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan 2. Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medicine and Dental Hospital, Niigata, Japan 3. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan 4. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan 5. Department of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan. 6. Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. 7. Department of Medical Oncology, Fukuchiyama City Hospital, Kyoto, Japan. 8. Department of Respiratory Medicine, Otsu City Hospital, Shiga, Japan 9. Department of Respiratory Medicine, Juntendo University, Tokyo, Japan 10. Division of Medical Oncology, Cancer Research Institute, Kanazawa University, Kanazawa, Japan 11. Department of Respiratory Medicine, Fujita Health University School of Medicine, Aichi, Japan 12. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan 13. Department of Thoracic Oncology, Osaka International Cancer Institution, Osaka, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine
Address	465, Kajii-cho, Kamigyo-ku, Kyoto,
Tel	075-251-5513
Email	aki-y@koto.kpu-m.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	2021 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
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	Completed
Date of protocol fixation	2018 Year 08 Month 02 Day
Date of IRB	2018 Year 08 Month 23 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 04 Month 15 Day
Last modified on	2022 Year 10 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050167