UMIN-CTR Clinical Trial

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
Institute	Niigata Lung Cancer Treatment Group
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029530