UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000006457
Receipt number	R000007663
Scientific Title	Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer harboring EGFR mutation who acquired resistance to prior gefitinib treatment (TAILORED-1 study)
Date of disclosure of the study information	2011/10/03
Last modified on	2011/10/03 11:40:52

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Basic information

Public title

Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer harboring EGFR mutation who acquired resistance to prior gefitinib treatment (TAILORED-1 study)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous and Non-Small Cell Lung Cancer harboring EGFR mutation who acquired resistance to prior gefitinib treatment

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Progression Free Survival

Key secondary outcomes

Response Rate
Disease Control Rate
Overall Survival
Safety

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Erlotinib 150mg/day, oral daily
Bevacizumab 15mg/kg, intravenous q3w

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)Histologically or cytologically confirmed non-squamous NSCLC
2)StageIIIB/IVor postoperative recurrence NSCLC
3)EGFR mutation(exon18,19,21) postive
4)The best response to prior gefitinib treatment is more than SD
5)Failed to prior chemotherapy or chemoradiotherapy(<3 regimens)
6)Measurable lesions(RECIST)
7)ECOG PS 0-2
8)Age>=20years
9)Expected survival over 3 months
10)Interval
i)Palliative Radiation Therapy
/More than 2 weeks
ii)Operation(except chest)
/More than 4 weeks
iii)Treatment of Brain metastasis
/More than 4 weeks
iv)Cranial nerves surgery
/More than 3 months
v)Thoracic drainage
/More than 2 weeks
vi)Incisional biopsy, Port detention, Measures against externally caused injury /More than 2 weeks
vii)Aspiration cytology
/More than 1week
11)Adequate function of main organ
12)Provided written informed consent

Key exclusion criteria

1) Squamous cell carcinoma
2)Interstitial pneumonia or pulmonary fibrosis on chest CT scans
3)
i)Brain metastasis expected bleeding
ii)Patients with untreated Brain metastasis
4)Active severe comorbidity disease
5)History of hemoptysis
6)Uncontrollable hypertension
7)History of gastrointestinal perforation or diverticulitis or fistula
8)Scheduled operation
9)History of grave drug allergic reaction
10)Active concomitant malignancy
11)Pregnant or breast-feeding females
12)Inappopriate patients for this study by the physicians

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Koji Inoue

Organization

Kitakyushu Municipal Medical Center

Division name

Respiratory medicine

Zip code

Address

2-1-1 Basyaku, Kokurakita-ku, Kitakyushu, JPAN, 802-0077

TEL

093-541-1831

Email

Public contact

Name of contact person

1st name

Middle name

Last name Taishi Harada

Organization

Graduate school of medical science, Kyushu University

Division name

Research Institute for disease of the Chest

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN, 812-8582

TEL

092-642-5378

Homepage URL

Email

Harada-t@kokyu.med.kyushu-u.ac.jp

Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name

Funding Source

Organization

Kyushu 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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学(福岡県)、北九州市立医療センター(福岡県)

Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 03 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

Open public recruiting

Date of protocol fixation

2011 Year 09 Month 10 Day

Date of IRB

Anticipated trial start date

2011 Year 10 Month 01 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

2011 Year 10 Month 03 Day

Last modified on

2011 Year 10 Month 03 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007663