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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026108
Receipt No. R000030004
Scientific Title Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Date of disclosure of the study information 2017/02/13
Last modified on 2019/08/19

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Basic information
Public title Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Acronym Study for acquired resistance mechanisms for afatinib using plasma samples
Scientific Title Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Scientific Title:Acronym Study for acquired resistance mechanisms for afatinib using plasma samples
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 The purpose of this prospective study is to determine the mechanisms of acquired resistance for afatinib as the first line treatment of non small cell lung cancer using plasma samples.
Basic objectives2 Others
Basic objectives -Others The study is to determine relation of detected mutations from ctDNA before afatiib treatment by NGS and effect of afatinib. Furthermore the study is to determine relation of detected mutations from ctDNA at acquired resistance to afatinib by NGS and effect of osimertinib.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Examination of variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.
Key secondary outcomes Examination of variety and rate of gene abnormality detected from ctDNA before and at the time of acquired resistance for afatinib.
Examination about correlation of gene abnormality detected from ctDNA and response rate, progression free survival and time to 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 1. StageIIIB or IV non-small cell lung cancer patients with EGFR activating mutations such as exon 19 deletion, L858R, L861Q and G719X.
2. Patient is treated with afatinib as the first line therapy.
3. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1).
4. Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically.
5. Non-small cell lung cancer patients with written consent.
Key exclusion criteria 1. Previously treated with an EGFR TKI.
2. Previously treated with an immune checkpoint inhibitor.
3. Patients who, in the opinion of the attending physician, are inappropriate for the study .
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Naoko
Middle name
Last name Aragane
Organization Saga Univ, Faculty of Medicine
Division name Division of Hematology, Respiratory Medicine and Oncology
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2369
Email sueokan@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Nakamura
Organization Saga Univ, Faculty of Medicine
Division name Division of Hematology, Respiratory Medicine and Oncology
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2369
Homepage URL
Email nakamurt@cc.saga-u.ac.jp

Sponsor
Institute Saga Univ,Clinical research center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical research center of saga university hospital
Address 5-1-1 Nabeshima, Saga, Japan
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-u.ac.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 13 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 29
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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 12 Day
Date of IRB
2017 Year 01 Month 12 Day
Anticipated trial start date
2017 Year 02 Month 20 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.

Management information
Registered date
2017 Year 02 Month 13 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030004

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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