UMIN-CTR Clinical Trial

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

Non small cell lung cancer

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

AstraZeneca K.K.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2016

Year

11

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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)

Registered date

2016

Year

11

Month

21

Day

Last modified on

2018

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028669