UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037452
Receipt No. R000042689
Scientific Title A observational study to evaluate afatinib followed by osimertinib
Date of disclosure of the study information 2019/07/22
Last modified on 2019/12/24

* 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 Sequential therapy from afatinib to osimertinib for EGFR-mutant non-small cell lung cancer: a multicenter prospective observational study (Gio-Tag Japan)
Acronym Gio-Tag Japan
Scientific Title A observational study to evaluate afatinib followed by osimertinib
Scientific Title:Acronym Afa-Osi for EGFR-mutant NSCLC
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate sequential therapy of first-line afatinib followed by osimertinib in a prospective Japanese real world data

To investigate T790M incidence after afatinib resistance using highly sensitive ddPCR in translational research
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Time on treatment of afatinib followed by osimertinib
Key secondary outcomes OS, RR/PFS of afatinib, RR/PFS of osimertinib, efficacy of afatinib by dosages, incidence of rebiopsy, positive-rate of T790M by cobas, positive-rate of T790M by ddPCR, TOT of afatinib followed by chemotherapy other than osimertinib, and TD-TKI

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. Written informed consent
2. Histologically or cytologically conformed NSCLC
3. EGFR-mutant (Del-19 or L858R)
4. Advanced disease without indication of surgery and CRT
5. Afatinib will be administered as the first-line therapy
6. Aged older than 20
7. PS (ECOG) 0/1
Key exclusion criteria 1. Active double cancer
2. No interstitial lung disease
3. No uncontrolled comorbidities
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Katakami
Organization Takarazuka City Hospital
Division name Department of Medical Oncology
Zip code 665-0827
Address 5-1, 4 chome, Kohama, Takarazuka
TEL 0797-87-1161
Email klog@jcom.zaq.ne.jp

Public contact
Name of contact person
1st name Akito
Middle name
Last name Hata
Organization Kobe Minimally Invasive Cancer Center
Division name Department of Thoracic Oncology
Zip code 650-0046
Address 8-5-1, Minatojima-nakamachi, Chuo-ku, Kobe
TEL 078-304-4100
Homepage URL
Email akitohata@hotmail.com

Sponsor
Institute HANSHIN Oncology Group
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 Takarazuka City Hospital
Address 5-1, 4 chome, Kohama, Takarazuka
Tel 0797-87-1161
Email klog@jcom.zaq.ne.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 全国から約60施設を予定

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 22 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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 22 Day
Date of IRB
2019 Year 07 Month 24 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2019 Year 07 Month 22 Day
Last modified on
2019 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042689

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.