UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038934 |
|---|---|
| Receipt number | R000044395 |
| Scientific Title | Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer |
| Date of disclosure of the study information | 2019/12/19 |
| Last modified on | 2021/12/20 17:22:31 |
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Basic information
Public title
Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer
Acronym
ALCURE(ALeCtinib Ultimate REsistance mechanisms study)
Scientific Title
Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer
Scientific Title:Acronym
ALCURE(ALeCtinib Ultimate REsistance mechanisms study)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To uncover the resistance mechanisms to alectinib, and to explore the relationship between the resistance mechanisms and efficacy of first-line alectinib or second-line therapy in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer.
Basic objectives2
Others
Basic objectives -Others
Efficacy of first-line alectinib and second-line therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To explore the resistance mechanisms to alectinib and relationship between the resistance mechanisms and efficacy of first-line alectinib and second-line therapy
Key secondary outcomes
To establish the patient derived cancer cell line and analyze the resistance mechanisms besides secondary mutations in ALK, and to analyze the immune microenvironment in ALK rearranged cancer
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)Patients 20 years of age or older at the time of signed consent.
(2)Patients with locally advanced or metastatic ALK-rearranged non-small cell lung cancer.
(3)Patients who treated with or are scheduled to start alectinib as first-line, based on the alectinib package insert.
(4)Patients who can submit a tissue sample collected before alectinib is administered.
(5)Patients who signed informed consent form before enrolling the study.
Key exclusion criteria
(1)Patients who are judged by physician in charge of a case to be inappropriate to participate in study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | KATAYAMA |
Organization
The Cancer Chemotherapy Center of Japanese Foundation for Cancer Research
Division name
Division of Experimental Chemotherapy
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL
03-3520-0111
ryohei.katayama@jfcr.or.jp
Public contact
Name of contact person
| 1st name | The ALCURE Study |
| Middle name | |
| Last name | Research Secretariat |
Organization
EP-CRSU Co.,Ltd.
Division name
Clinical Research Headquarters
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo,162-0814, JAPAN
TEL
03-5804-5045
Homepage URL
prj-alcure@eps.co.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research / CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
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
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2019 | Year | 12 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is a non-interventional, unblinded, non-randomized, single-arm, observational study to be conducted under clinical settings that will use healthcare information obtained as the result of providing care most appropriate to patients with no restrictions on the use and extent of tests, medications, and other medical acts performed for diagnostic or therapeutic reasons.
Management information
Registered date
| 2019 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044395
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
