UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026019
Receipt number R000029530
Scientific Title Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer
Date of disclosure of the study information 2017/02/07
Last modified on 2021/05/10 18:43:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer

Acronym

Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer

Scientific Title

Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer

Scientific Title:Acronym

Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Execution rate of re-biopsy in secondarily registered patients
Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.

Basic objectives2

Others

Basic objectives -Others

Execution rate of re-biopsy in secondarily registered patients
Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Execution rate of re-biopsy in secondarily registered patients
Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.

Key secondary outcomes

Success rate of re-biopsy (= Number of patients with detected cancer cells / Number of re-biopsies performed), Individual test modalities (for bronchoscopy, confirm whether EBUS-TBNA or EBUS-GS has been performed or not) / Positive T790M mutation rate by biopsy site (= Number of patients with positive T790M mutation / Number of patients with detected cancer cells), Safety of individual test modalities, Analysis of reasons for patients not undergoing re-biopsy after secondary registration, Execution rate of re-biopsy by use or non-use of each test modality (e.g., EBUS-TBNA, EBUS-GS, CT-guided biopsy), Investigation of prognosis at 1 year after secondary registration (including the type of subsequent treatment)


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

Primary registration:
1) Histologically or cytologically confirmed non-small cell lung cancer
2) Stage III/IV not amenable to definitive radiation therapy or postoperative recurrence at the start of EGFR-TKI therapy
3) Presence of any EGFR-activating mutation (Exon 19 del, L858R, or uncommon mutation) confirmed by tissue or cell genetic testing before the start of EGFR-TKI therapy
4) Ongoing EGFR-TKI (gefitinib, erlotinib, afatinib) therapy
5) No T790M mutation detected after the start of EGFR-TKI therapy
6) Written informed consent for study participation from the patient

Secondary registration:
1) Sustained response to EGFR-TKI (CR, PR, or SD for>6 weeks)
2) Confirmed (or concerned about) development of resistance to EGFR-TKI
In this study, development of resistance is defined as any of the three conditions below and determined by the treating physician according to the patient's condition:
(i) PD assessed by RECIST
(ii) PD assessed clinically
(iii) SD assessed by RECIST with an increasing tendency of the tumor compared with baseline

Key exclusion criteria

Treatment by 3rd generation EGFR-TKI

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Toshiaki
Middle name
Last name Kikuchi

Organization

Niigata university graduate school of medicine and dental sciences

Division name

Department of respiratory medicine and infectious disease

Zip code

9518510

Address

1-754 Asahimachi-dori,Chuo-ku,Niigata city

TEL

025-368-9324

Email

kikuchi@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Koyama

Organization

Niigata cancer center hospital

Division name

Department of internal medicine

Zip code

9518566

Address

2-15-3 Kawagishi-cho,Chuo-ku,Niigata city

TEL

025-266-5111

Homepage URL


Email

k-koyama@niigata-cc.jp


Sponsor or person

Institute

Niigata Lung Cancer Treatment Group

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca

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

Niigata cancer center hospital

Address

2-15-3 Kawagishi-cho,Chuo-ku,Niigata city

Tel

025-266-5111

Email

k-koide@niigata-cc.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 02 Month 07 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

Completed

Date of protocol fixation

2017 Year 02 Month 03 Day

Date of IRB

2017 Year 08 Month 09 Day

Anticipated trial start date

2017 Year 02 Month 08 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2021 Year 05 Month 31 Day


Other

Other related information

Investigational Items at Primary Enrollment
Patient demographic information: Age, sex, Eastern Cooperative Oncology Group - Performance Status (ECOG-PS), history of smoking
Information at diagnosis: Histologic type (adenocarcinoma, squamous cell carcinoma, other carcinomas), clinical stage, testing method used to confirm the diagnosis, EGFR gene mutation status
Information on treatment: History of surgery, postoperative adjuvant chemotherapy, chest irradiation, history of TKI therapy, treatment line

Investigational Items at Secondary Enrollment
Information on treatment: Type of TKI, dose administered, date of first dose, date of last dose, reason for discontinuation, PS at discontinuation, best overall response, dose reduced or not
Information on re-biopsy: Site(s) of exacerbation (primary lesion, intrapulmonary metastasis, pleural effusion, mediastinal lymph node, CNS, adrenal gland, bone, liver, extrathoracic lymph node), the greatest dimension if measurable, number of sites, re-biopsy performed or not, testing method and result if re-biopsy has been performed, complications related to re-biopsy observed or not, reason if re-biopsy has not been performed
The testing method, the reason for not performing re-biopsy, and the test result will be recorded by selecting the respective relevant numbers from the numbers listed the reference document.
For any repeated re-biopsy or re-biopsy requested to a different medical institution, the information for repeated re-biopsy will be entered (In the case of the request from a different medical institution, the doctor in charge requesting re-biopsy must enter the the data.).

Investigation of Prognosis
Subsequent treatment planned or not, the content of the treatment, the effect of the treatment, the duration of the treatment, outcome, the duration of survival
(A form for the investigation of prognosis will be sent to each study site from the administrative office by one year after secondary enrollment)


Management information

Registered date

2017 Year 02 Month 06 Day

Last modified on

2021 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029530


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name