UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Koichi Goto
Organization	National Cancer Center Hospital East
Division name	Division of Thoracic Oncology
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	Kiyotaka Yoh
Organization	National Cancer Center Hospital East
Division name	Division of Thoracic Oncology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S2213260016303228
Results
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