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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044049
Receipt No. R000050182
Scientific Title Prospective observation study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Date of disclosure of the study information 2021/04/27
Last modified on 2021/04/27

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Basic information
Public title Prospective observation study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Acronym Prospective observation study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Scientific Title Prospective observation study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Scientific Title:Acronym Prospective observation study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Region
Japan

Condition
Condition EGFR mutated non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of first/second generation EGFR-TKI rechallenge in EGFR mutated non-small cell lung cancer patients after osimertinib resistance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression Free Survival: PFS
Key secondary outcomes Overall survival: OS
Time to treatment failure: TTF
Disease control rate: DCR
Deepness of Response: DpR
And others

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) A patient with evaluable lesions by RECIST (version 1.1)
2) A patient with EGFR active mutation (at least one of the following: EGFR exon19 deletion, EGFR-Exon20 S768I mutation, EGFR exon21-L858R, L861Q mutation, exon18-G719X point mutation)
3) A patient with disease progression after osimertinib treatment
Key exclusion criteria 1) A patient whose previous treatment with osimertinib was discontinued due to toxicity
2) A patient with no target lesions
3) A patient who have already received a first/second generation EGFR-TKI after osimertinib resistance
4) A patient who is judged ineligible to enroll the study by an attending doctor.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Tadaaki
Middle name
Last name Yamada
Organization University Hospital, Kyoto Prefectural University of Medicine
Division name Department of pulmonary medicine
Zip code 602-8566
Address 465, Kajii-cho, Kamigyo-ku, Kyoto
TEL 075-251-5513
Email tayamada@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Tadaaki
Middle name
Last name Yamada
Organization University Hospital, Kyoto Prefectural University of Medicine
Division name Department of pulmonary medicine
Zip code 602-8566
Address 465, Kajii-cho, Kamigyo-ku, Kyoto
TEL 075-251-5513
Homepage URL
Email m-kenji@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
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 Ethics Review Board of Kyoto Prefectural University of Medicine
Address 465, Kajii-cho, Kamigyo-ku, Kyoto
Tel 075-251-5337
Email rinri@koto.kpu-m.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
2021 Year 04 Month 27 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
2020 Year 03 Month 27 Day
Date of IRB
2020 Year 06 Month 05 Day
Anticipated trial start date
2020 Year 06 Month 05 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A multicenter prospective observational study
Eligibility criteria include patients who are to receive first/second generation EGFR-TKI rechallenge therapy after osimertinib resistance in a practical setting in each participating institution and those who provide written informed consent.

Management information
Registered date
2021 Year 04 Month 27 Day
Last modified on
2021 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050182

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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