UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044049 |
|---|---|
| Receipt number | R000050182 |
| Scientific Title | Prospective observational 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 | 2023/08/23 21:58:35 |
* 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
Prospective observational study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Acronym
Prospective observational study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Scientific Title
Prospective observational study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients
Scientific Title:Acronym
Prospective observational 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
Depth 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
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
m-kenji@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11523-023-00991-5
Number of participants that the trial has enrolled
30
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
Main results already published
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
| 2023 | 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
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.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 |
