UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000012515
Receipt number	R000014649
Scientific Title	To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation.
Date of disclosure of the study information	2013/12/09
Last modified on	2017/12/11 14:05:19

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Basic information

Public title

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

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

time to treatment failure after secondary enrollment

Key secondary outcomes

Toxicity
Response Rate for intracranial metastases
Overall survival

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

first enrollment
1)Histologically or cytologically confirmed non-squamous NSCLC
2)StageIIIB/IV or postoperative recurrence NSCLC
3)EGFR mutation(exon18,19,21) positive
4)EGFR-TKI treatment or plan treatment
5)Age>=20years
6)Patients without previous treatment for lung cancer
A patient who has received postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 months
7)ECOG PS 0-2
8)Written informed consent from the patients.
second enrollment
1)metastasis to brain during EGFR-TKI treatment
2)best effect that was higher than SD was accepted in EGFR-TKI monotherapy
3)Adequate function of main organ evaluated within enrollment as
WBC=3,000~12000/mm3
Neu>=1,500/mm3
Plt>=10.0x10000/mm3
hemoglobin >=8.5g/dL
AST,ALT=<2.5xULN
T-bil=<2.0mg/dL
Cr>=2.0xULN
Proteinuria<1+
SpO2>=90%

Key exclusion criteria

first enrollment
1)Squamous cell carcinoma
2)brain metastasis
3)Pregnant or breast-feeding females

second enrollment
1)Interstitial pneumonia or pulmonary fibrosis on chest CT scans
2)History of EGFR-TKI, VEGF antibody allergic reaction.
3)Radiotherapy enforcement example for the brain
4)Brain metastasis expected bleeding
5)Active severe comorbidity disease.
6)History of hemoptysis
7)Uncontrollable hypertension
8)History of gastrointenstinal perforation or diverticulitis or fistula
9)Scheduled operation
10)Active concomitant malignancy
11)Pregnant or breast-feeding females
12)Inappropriate patients for this study judged by the physicians

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Sho Saeki

Organization

Kumamoto University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-1-1 Honjo,Chuo-ku,Kumamoto city,Kumamoto,Japan

TEL

096-373-5012

Email

saeshow@wg7.so-net.ne.jp

Public contact

Name of contact person

1st name

Middle name

Last name Sho Saeki

Organization

Kumamoto University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-1-1 Honjo,Chuo-ku,Kumamoto city,Kumamoto,Japan

TEL

096-373-5012

Homepage URL

Email

saeshow@wg7.so-net.ne.jp

Sponsor or person

Institute

Department of Respiratory Medicine, Kumamoto University Hospital

Institute

Department

Personal name

Funding Source

Organization

Kumamoto University Hospital

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

Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 09 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

Preinitiation

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB

Anticipated trial start date

2013 Year 12 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

2013 Year 12 Month 07 Day

Last modified on

2017 Year 12 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014649