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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024928
Receipt No. R000028669
Scientific Title Real world molecular testing among patients with EGFR mutation positive NSCLC following progression on an EGFR-TKI in Japan
Date of disclosure of the study information 2016/11/24
Last modified on 2018/04/20

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Basic information
Public title Real world molecular testing among patients with EGFR mutation positive NSCLC following progression on an EGFR-TKI in Japan
Acronym Real world molecular testing in the EGFR-TKI failure patients
(REMEDY Study)
Scientific Title Real world molecular testing among patients with EGFR mutation positive NSCLC following progression on an EGFR-TKI in Japan
Scientific Title:Acronym Real world molecular testing in the EGFR-TKI failure patients
(REMEDY Study)
Region
Japan

Condition
Condition Non small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To demonstrate the real-world situation of re-biopsy and T790M testing in the advanced non-small cell lung cancer patients having disease progression during EGFR-TKI treatments
Basic objectives2 Others
Basic objectives -Others Nothing specially
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ・Re-biopsy ratio among the patients who had disease progression during EGFR-TKI treatment : All, by kind of sample

・The kind of sample for re-biopsy and the reason why its sample is selected.

・The mutation assay pattern to decide which treatment for next line: sample / assay method.

・The reason why re-biopsy is not performed
Key secondary outcomes ・Timing to conduct re-biopsy and its status; the lesion at biopsy, biopsy method (e.g. core needle, FNA, excisional biopsy) and success rate of re-biopsy by samples.

・Occurrence of complications at re-biopsy, type of complications and its outcome.

・Kind of treatment and its duration till PD

・A site of recurrence after EGFR-TKI therapy

・Subsequent treatment pattern after re-biopsy (e.g., chemotherapy/targeted therapy used, palliative care, starting time of the next treatment line) by availability of re-biopsy and T790M testing, and/or by T790M testing outcome

・T790M prevalence among previous EGFR-TKI treatments and EGFR mutation sub-type at diagnosis

・In case other treatment is conducted after judgement of PD prior to re-biopsy [beyond PD, radiation therapy, et al], the detailed information of the treatment (method, timing, period)

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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Age more than 20 y.o.
2.Able to obtain Informed Consent Form
3.Diagnosed advanced non-small cell lung cancer with EGFR mutation
4.Investigator judged "Disease Progress" during EGFR-TKI treatment.
Key exclusion criteria 1.Patients who the investigator judged retrospective review of medical charts or information on pre-progression medical history at the participating site cannot be done.
2.Patients already given T790M targeting EGFR-TKI
3.Patients having EGFR-TKI treatment with more than two different TKIs, except EGFR-TKI switching patients with toxicity reason
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Seto
Organization National Hospital Organization
Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 1-1 3-chome, Notame, Minamiku, Fukuoka-city, Fukuoka
TEL 092-541-3231
Email tseto@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Yoshimura
Organization AstraZeneca K.K.
Division name Medical Division
Zip code
Address 3-1, Ofuka-cho, Kita-ku, Osaka
TEL 06-7711-3560
Homepage URL
Email Yoko.Yoshimura@astrazeneca.com

Sponsor
Institute AstraZeneca K.K.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 国立病院機構 がん(呼吸器)ネットワークグループに所属する施設

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 24 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)
In the present study, the proportion of patients who could be identified as T790M mutation positive was approximately 26%. Liquid biopsy was most frequently used for T790M testing, but the T790M detection rate was lower with plasma samples (19.7%) compared with adequate tissue/cytology samples (approximately 40%).

(Conclusion)
In conclusion, approximately 26% of patients with EGFR mutated NSCLC who reported disease progression during first- or second-generation EGFR-TKI treatment were identified as T790M mutation-positive in real-world clinical setting. Tissue re-biopsy for T790M testing is important to secure the identification of the right patients for the right (targeted) treatment because of the lower T790M detection rate of plasma.  
Furthermore, when T790M testing showed negative after first re-biopsy, more than second re-biopsy may be considered to conduct in order to reduce the risk of underestimating T790M mutation due to false-negative 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
2016 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 25 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 11 Month 10 Day
Date analysis concluded
2017 Year 11 Month 30 Day

Other
Other related information Observational Research
(Exposure) Re-biopsy, T790M testing
(Outcome)
・Conducting ratio/Success rate of Re-biopsy/ T790M testing
・Determined drug therapy based on the above assay/testing result

・The NSCLC patient with EGFR mutation positive had a diagnosis of Progressive Disease during EGFR-TKI treatment, and was provide informed consent (Registration period: January, 2017 to Aug, 2017)

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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