UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035180 |
|---|---|
| Receipt number | R000040096 |
| Scientific Title | Biomarker analysis for alectinib and bevacizumab in ALK-positive NSCLC |
| Date of disclosure of the study information | 2018/12/08 |
| Last modified on | 2022/12/12 09:54:07 |
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Basic information
Public title
Biomarker analysis for alectinib and bevacizumab in ALK-positive NSCLC
Acronym
NLCTG1501-BM
Scientific Title
Biomarker analysis for alectinib and bevacizumab in ALK-positive NSCLC
Scientific Title:Acronym
NLCTG1501-BM
Region
| Japan |
Condition
Condition
ALK-positive non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the biomarker for the combination therapy of alectinib and bevacizumab in ALK-positive NSCLC.
Basic objectives2
Others
Basic objectives -Others
To determine the biomarker for the combination therapy of alectinib and bevacizumab in ALK-positive NSCLC, liquid biopsy will be performed.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the biomarker for the combination therapy of alectinib and bevacizumab in ALK-positive NSCLC.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
According to NLCTG1501
Key exclusion criteria
According to NLCTG1501
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Toshoaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518510
Address
1-757 Asahimachidori, Chuouku, Niigata, Japan
TEL
025-368-9325
kikuchi@med.niigta-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518510
Address
1-757 Asahimachidori, Chuouku, Niigata, Japan
TEL
025-368-9325
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Niigata University
Address
1-754 Asahimachidori, Chuouku, Niigata, Japan
Tel
025-2272625
sanonao@adm.niigata-u.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
| 2018 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Partially published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
12
Results
There was no difference in PFS or OS by serum biomarkers, but there was a trend toward longer PFS in patients with some biomarker positivity.
Results date posted
| 2021 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twelve patients with a median age of 67 years (range, 30-77) were enrolled between July 2015 and September 2018. Ten patients were female, all patients had adenocarcinoma histology with advanced ALK-positive NSCLC which were determined by fluorescence in situ hybridization, immunohistochemistry and/or reverse transcription PCR. All patients had received alectinib and a half of patients had been treated with 3 or more regimens before enrollment. At the time of data cutoff, the median follow-up for OS was 13.7 months for all patients and 26.4 months for living patients.
Participant flow
Patients who participated in the NLCTG1501 study were enrolled in the study.
Adverse events
NA
Outcome measures
Potential biomarkers in the plasma proteins were evaluated at baseline, 6 weeks, 12 weeks after the initiation of the combination therapy and when disease progressed. Fresh blood samples (14 ml) were collected in EDTA tubes and centrifuged for 10 minutes at 1400 g at room temperature to separate plasma and buffy coats. All samples were stored at -80 C until the analysis. Cell free DNA (cfDNA) was subsequently extracted from the plasma using an AVENIO cfDNA isolation kit (Roche diagnostics, Mannheim, Germany). Sample plasma analysis was carried out for a panel of circulating angiogenesis and cytokines: angiopoietin-2, bone morphogenetic protein (BMP)-9, epidermal growth factor (EGF), endoglin, fibroblast growth factor (FGF)-1, placental growth factor (PLGF), granulocyte-colony stimulating factor (G-CSF), heparin-binding EGF-like growth factor (HB-EGF), endotherin-1, Hepatocyte Growth Factor (HGF), follistatin, leptin, VEGF-A, VEGF-C, VEGF-D using Bio-Plex 200 (Bio-Rad, Hercules, USA) and Human Angiogenesis/Growth Factor Magnetic Bead Panel (Merck Millipore, Burlington, USA).
The circulating tumor DNA (ctDNA) samples were analyzed with NextSeq500 (Illumina, San Diego, USA) and AVENIO ctDNA Surveillance Kit , which can detect mutations in 197 genes (Roche Diagnostics).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 12 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Evaluate tumor DNA and RNA from plasma of patients treated in NLCTG1501 trial.
Management information
Registered date
| 2018 | Year | 12 | Month | 08 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040096
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