UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028166 |
|---|---|
| Receipt number | R000031670 |
| Scientific Title | Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/01/17 22:32:06 |
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Basic information
Public title
Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib
Acronym
Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib (ALCSG-04)
Scientific Title
Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib
Scientific Title:Acronym
Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib (ALCSG-04)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of osimertinib in patients harboring EGFR T790M mutation who acquired resistance to afatinib as first line.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility includes;
1. Patients of lung cancer diagnosed with pathological findings and clinical stage from IIIA to IV.
2. Patients harboring active EGFR gene mutations.
3. Patients having one or more measurable lesions based on RECIST v1.1.
4. Patients aged 20 and over 20, and less than 75 years.
5. Patients who are not treated with chemotherapy, EGFR-TKIs, and Immuno-checkpoint blockades.
6. Patients who can take EGFR-TKIs orally.
7. Patients having adequate organ function.
8. Letter of consent.
Key exclusion criteria
Patients are excluded if they have;
1. Severe concomitant disease.
2. Severe history oh hypersensitivity.
3. Severe heart disease or arrhythmia.
4. Interstitial pneumoniae.
5. Active infection.
6. Active peptic ulcer.
7. Active double cancer.
8. Symptomatic brain metastasis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Sasaki |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
0166-65-2111
yryohei@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Onishi |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
0166-65-2111
Homepage URL
k-onishi@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University Hospital, Respiratory center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa Lung Cancer Study Group(ALCSG)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Hospital
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
Tel
0166-65-2111
k-onishi@asahikawa-med.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 | 08 | Month | 01 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No mention.
Management information
Registered date
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031670
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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