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

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)

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)

Scientific Title:Acronym

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)

Region

Japan


Condition

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


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

1

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

30


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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name