UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028989 |
|---|---|
| Receipt number | R000033169 |
| Scientific Title | Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer |
| Date of disclosure of the study information | 2017/09/10 |
| Last modified on | 2020/09/07 08:47:06 |
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Basic information
Public title
Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Acronym
Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Scientific Title
Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Scientific Title:Acronym
Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1) To reveal the real world utilization of the key drugs such as 1st generation of EGFR-TKI, 2nd generation of EGFR-TKI, Osimertinib, immune checkpoint inhibitors (ICIs), and platinum doublets in the patients with EGFR mutation-positive advanced/recurrent non-Sq NSCLC, and search the best treatment sequence of these drugs.
2) Genetic analysis of the mechanisms of responsiveness and acquired resistance to Osimertinib.
Basic objectives2
Others
Basic objectives -Others
Data cllection of real world treatments
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
To reveal real world clinical utility of Osimertinib in EGFR-mutant non-Sq NSCLC
1)Frequency of Osimertinib utilization after 1st or 2nd generation EGFR-TKI
2)Line of Osimertinib administration
3)Efficacy of Osimertinib
4)Toxicities of Osimertinib
Key secondary outcomes
1)To reveal real world treatments and their results for EGFR-mutant non-Sq NSCLC
2)To reveal the factors contributing to OS prolongation
3)Osimertinib-related part:
1.Frequency and success rate of re-biopsy
2.Efficacy of Osimertinib in CNS
3.Pattern, frequency, and severity of interstitial pneumonitis (IP) by Osimertinib
4)Osimertinib-unrelated part
1.Line of Nivolumab (and the other ICI monotherapy) administration
2.Response rate, disease control rate, and PFS of Nivolumab (and the other ICI monotherapy) in EGFR-mutated NSCLC
3.Accumulation and analysis of the cases who received an EGFR-TKI after ICIs.
5)To reveal interactions among different treatments especially that with ICI
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
I. Patients with histologically or cytologically confirmed EGFR mutation-positive advanced/recurrent non-Sq NSCLC (including minor mutation)
II. Patients who received or are planning to receive any drug therapy for NSCLC after 01 June 2016.
(Data are collected from the patients who actually received drug therapy after 01 June 2016.)
III. Sufficient functions of the main organs
IV. PS 0-2 at the start of initial drug therapy
Key exclusion criteria
Patients judged by the investigator to be unsuitable for the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka International Cancer Institute
Division name
Department of Thoracic Oncology
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567
TEL
+81-6-6945-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka International Cancer Institute
Division name
Department of Thoracic Oncology
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567
TEL
+81-6-6945-1181
Homepage URL
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
Osaka International Cancer Institute
Address
-1-69 Otemae, Chuo-ku, Osaka 541-8567
Tel
+81669721181
imamura-fu@mc.pref.osaka.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 | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
524
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 | 09 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2017 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033169
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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