UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Acronym	A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Scientific Title	A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Scientific Title:Acronym	A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Region	Japan

Condition
Condition	Patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility and efficacy of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Safety, Response rate, Improvement rate of performance status, Overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Osimertinib
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) ECOG PS 2, 3, or 4 2) Pathologically confirmation of non squamous non-small-cell lung cancer 3) Advanced non-small-cell lung cancer 4) History of using first-generation or second-generation EGFR-TKI 5) EGFR mutation with T790M in exon 20 6) Aged 20 or more 7) Written informed consent
Key exclusion criteria	1) History of using third-generation EGFR-TKI 2) Uncontrolled symptomatic brain metastasis 3) Interstitial pneumonia or pulmonary fibrosis on imaging 4) QTc > 500 msec 5) Gastrointestinal disorder 6) Uncontrollable pleural effusion , ascites or pericardial effusion 7) Receiving the radiation therapy for chest 8) 28th or less days from the last dosage of immunocheckpoint therapy 9) Severe complication
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Haruyasu Middle name Last name Murakami
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	(+81)055-989-5222
Email	ha.murakami@scchr.jp

Public contact
Name of contact person	1st name Kazuhisa Middle name Last name Nakashima
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code	693-8501
Address	89-1 Enya-cho, Izumo, Shimane
TEL	(+81)055-989-5222
Homepage URL
Email	kazuhin@med.shimane-u.ac.jp

Sponsor
Institute	Division of Thoracic Oncology, Shizuoka cancer center
Institute
Department

Funding Source
Organization	None
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 of Shizuoka Cancer Center
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel	(+81)055-989-5222
Email	irb@scchr.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	2017 Year 06 Month 07 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	18
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	2017 Year 03 Month 10 Day
Date of IRB	2017 Year 05 Month 29 Day
Anticipated trial start date	2017 Year 06 Month 12 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 06 Day
Last modified on	2020 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031682