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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010095
Receipt No. R000011780
Scientific Title A Phase II, Open-label Single-Arm Study to Evaluate the efficacy and Safety of Vandetanib in Patients with RET Fusion-positive Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Date of disclosure of the study information 2013/02/22
Last modified on 2016/12/14

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Basic information
Public title A Phase II, Open-label Single-Arm Study to Evaluate the efficacy and Safety of Vandetanib in Patients with RET Fusion-positive Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Acronym LURET
Scientific Title A Phase II, Open-label Single-Arm Study to Evaluate the efficacy and Safety of Vandetanib in Patients with RET Fusion-positive Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Scientific Title:Acronym LURET
Region
Japan

Condition
Condition Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer with RET Fusion-positive
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to evaluate the objective response rate (ORR) in patients with RET fusion-positive unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) treated at vandetanib.
Basic objectives2 Others
Basic objectives -Others 1. To evaluate progression-free survival (PFS) in patients treated at vandetanib.
2. To evaluate disease control rate (CR+PR+SD [>8 weeks]) in patients treated at vandetanib.
3. To assess the duration of response in patients treated at vandetanib.
4. .To evaluate overall survival (OS) in patients treated at vandetanib.
5. To evaluate the safety and tolerability in patients treated at vandetanib.
6. To explore the efficacy of cytotoxic chemotherapy for RET fusion-positive NSCLC using the previous or post treatment data.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Primary outcome variable-ORR
Key secondary outcomes Adverse events
PFS
DCR
Duration of response
OS
The efficacy of cytotoxic chemotherapy for RET fusion-positive NSCLC will be reported using the previous or post treatment data

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vandetanib at 300 mg using 3 x vandetanib tablets 100 mg will be dosed orally, once daily.
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. Written informed consent
2. Female or male aged 20 years and over
3. Histologically or cytologically confirmation of non-squamous NSCLC
4. Unresectable locally advanced or metastatic disease
5. Positive for RET fusion determined by tumor sample
6. EGFR mutation negative
7. ALK fusion negative
8. Progressive of NSCLC after at least one prior chemotherapy regimen
9. Life expectancy of 3 months or longer
10. ECOG Performance status 0-2
11. Negative pregnancy test for female patients of childbearing potential
12. One or more measurable disease by RECIST
13. Adequate bone marrow function
Key exclusion criteria 1. The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 4 weeks before the start of study therapy
2. The last radiation therapy within 4 weeks before the start of study therapy
3. Major surgery within 4 weeks before the start of study therapy, or incompletely healed surgical incision
4. Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy
5. Significant cardiac event, superior vena cava syndrome, New York Heart Association classification of heart disease &#8805;2, within 12 weeks before registration
6. History of arrhythmia, which is symptomatic or requires treatment (CTCAE grade 3)
7. Congenital long QTc syndrome
8. QTc prolongation with other medications that required discontinuation of that medication
9. Potassium concentration <4.0 mEq/L, calcium or magnesium concentrations outside of normal limits at each site despite supplementation
10. Currently pregnant or breast feeding
11. Any concomitant medications that have been associated with Torsades de Pointes or strong inducers of CYP3A4 function within 2 weeks of start of study treatment.
12. Unstable brain metastases or spinal cord compression that requires treatment
13. Hypertension not controlled by medical therapy
14. Previous or current malignancies of other histologies within the last 5 years
15. Evidence of severe or uncontrolled systemic disease
16. Any evidence of clinically active interstitial lung disease
17. Previous exposure to vandetanib
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Goto
Organization National Cancer Center Hospital East
Division name Division of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email ret_core@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka Yoh
Organization National Cancer Center Hospital East
Division name Division of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email ret_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare/Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor AstraZeneca/Sanofi
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S2213260016303228
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 Main results already published
Date of protocol fixation
2012 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 22 Day
Last modified on
2016 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011780

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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