UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Acronym	Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Scientific Title	Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Scientific Title:Acronym	Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Region	Japan

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

Objectives
Narrative objectives1	To assess safety and efficacy of osimertinib treatment on EGFR T790M cytology positive non-small cell lung cancer patients who acquired resistance to EGFR tyrosine kinase inhibitors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall response rate: from first administration to last administration
Key secondary outcomes	1) disease control rate 2) progression-free survival 3) safety (adverse event)

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	Continue to administer osimertinib to a patient until the patient correspond to the withdrawal criteria
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) Non-small cell lung cancer (except for squamous cell carcinoma) diagnosed histologically or cytologically 2) Patients with EGFR mutation (Exon 19 deletion or Exon21 L858R) positive, who were received treatment by EGFR tyrosine kinase inhibitors 3) Patients with clinical stages IIIB, IIIC or IV or postoperative recurrence which are confirmed with diagnostic radiology 4) EGFR T790M positive cytology positive 5) Enrollment after 12 weeks from radiation therapy including lung area and after 1 week from radiation therapy not including lung area 6) Age: more than 20 years old at the date or informed consent 7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1 8) Patients who have measurable lesion designated by RECIST version 1.1 9) Patients with adequate organ function 10) Enrollment after 21 days from the starting date of last cytotoxic anticancer agents or after 4 days from the last dose of EGFR tyrosine kinase inhibitors 11) Patients expected to survive for more than 12 weeks 12) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained
Key exclusion criteria	1) Treatment history of osimertinib or other third-generation EGFR tyrosine kinase inhibitors (ex. ASP8273) 2) Patients who received other EGFR-tyrosine kinase inhibitors again after disease progression 3) Treatment history of immune checkpoint inhibitors 4) QTc >470 msec 5) Patients with interstitial pneumonia, pulmonary fibrosis or radiation pneumonitis on chest CT 6) Patients with history of drug-related interstitial lung disease 7) Patients with history of serious drug allergy 8) Patients with serious infection or other serious concomitant disease (ex. gastrointestinal bleeding) 9) Uncontrollable pleural effusion, ascites or pericardial effusion 10) Clinically problematic heart disease 11) Uncontrollable diabetes 12) Central nervous system metastasis with a clinical manifestation 13) Patients with active double cancer 14) Clinically problematic psychiatric disorders 15) Unhealed fracture or heavy wound 16) Pregnant or breast-feeding female patients, female patients who have a possibility of pregnancy and does not intend to use birth control till after 6 weeks after last administration or male patients who does not intend to use birth control till after 4 months after last administration 17) Patients judged to be ineligible for safe implementation of this trial by the investigators
Target sample size	58

Research contact person
Last name of lead principal investigator	1st name Nobuyuki Middle name Last name Katakami
Organization	Kobe City Medical Center General Hospital
Division name	Department of medical oncology
Zip code	6500047
Address	2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047
TEL	078-302-4321
Email	katakami@fbri.org

Public contact
1st name of contact person	1st name Tatsushi Middle name Last name Goto
Organization	Secretariat of clinical trial coordinating committee
Division name	none
Zip code	5300044
Address	Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka, 530-0044 Japan
TEL	06-6358-7110
Homepage URL
Email	gotou@fiverings.co.jp

Sponsor
Institute	Kobe City Medical Center General Hospital Department of medical oncology
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
Organization
Division
Category of Funding Organization	Profit organization
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	独立行政法人国立病院機構 北海道がんセンター（北海道）、一般財団法人厚生会 仙台厚生病院（宮城県）、愛知県がんセンター中央病院（愛知県）、社会福祉法人京都社会事業財団 京都桂病院（京都府）、関西医科大学附属病院（大阪府）、独立行政法人国立病院機構 刀根山病院（大阪府）、大阪市立総合医療センター（大阪府）、神戸大学医学部附属病院（兵庫県）、地方独立行政法人大阪府立病院機構 大阪国際がんセンター（大阪府）、地方独立行政法人神戸市民病院機構 神戸市立医療センター中央市民病院（兵庫県）、兵庫県立がんセンター（兵庫県）、独立行政法人国立病院機構 四国がんセンター（愛媛県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 30 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	6
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	Terminated
Date of protocol fixation	2017 Year 09 Month 22 Day
Date of IRB	2017 Year 10 Month 11 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2018 Year 11 Month 26 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 10 Month 30 Day
Last modified on	2019 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033810