UMIN-CTR Clinical Trial

Basic information
Public title	The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton (L858R and delition 19): HOPE-002
Acronym	The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton: HOPE-002
Scientific Title	The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton (L858R and delition 19): HOPE-002
Scientific Title:Acronym	The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton: HOPE-002
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Evaluate the predictive marker for detecting T790M from the patient background in stage4 NSCLC patients harbering EGFR mutation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the predictive marker for detecting T790M from the patient background in stage4 NSCLC patients harbering EGFR mutation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	stage4 NSCLC EGFR mutation (L858R or deliton10) positive
Key exclusion criteria	recurrent patient
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Tamiya
Organization	Osaka International Cancer Institute
Division name	Thoracic Oncology
Zip code	541-8567
Address	3-1-69 Otemae Chuo-ku Osaka
TEL	06-6945-1181
Email	moto19781205@yahoo.co.jp

Public contact
Name of contact person	1st name Motohiro Middle name Last name Tamiya
Organization	Osaka International Cancer Institute
Division name	Thoracic Oncology
Zip code	541-8567
Address	3-1-69 Otemae Chuo-ku Osaka
TEL	06-6945-1181
Homepage URL
Email	moto19781205@yahoo.co.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Boehringer Ingelheim
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	Osaka International Cancer Institute
Address	3-1-69 Otemae Chuo-ku Osaka
Tel	06-6945-1181
Email	moto19781205@yahoo.co.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	2020 Year 08 Month 21 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	Preinitiation
Date of protocol fixation	2018 Year 12 Month 18 Day
Date of IRB	2018 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 22 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2020 Year 08 Month 20 Day
Last modified on	2020 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047342