UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010095
Receipt number 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 09:53:13

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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 or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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

Value
https://center6.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