UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014710
Receipt number R000017092
Scientific Title Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLC
Date of disclosure of the study information 2014/08/01
Last modified on 2017/12/24 15:54:32

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Basic information

Public title

Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLC

Acronym

Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI

Scientific Title

Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLC

Scientific Title:Acronym

Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the efficacy and safety of Afatinib plus Bevacizumab in patients with EGFR-mutant NSCLC after acquired resistance to EGFR-TKI

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival
Disease control rate
Overall survival
Safety


Base

Study type


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

Afatinib is prescribed at 30 mg/day everyday, and bevacizumab is injected at 15 mg/kg every 3 weeks until progressive disease.

If possible, rebiopsy is performed to confirm T790M status.

To evaluate the safety, the traetment of afatinib should be administered at 30 mg/day in initial 6 cases only at institute of Biomedical Reseach and Innovation. After the treatment of this 6 cases, Data and Safety Monitoring Committee will judge the trial proceeding, based on safety results of this 6 cases.

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)Histological or cytological proven NSCLC (except squamous hislotogy)
2)EGFR mutation positive
3)After acquired resistance to EGFR-TKI (briefly, SD>6 months, defined by Jackman criteria)
4)Interval of radiation therapy: 4 weeks after thoracic RT and 1 week after non-thoracic RT
5)Age: over 20
6)ECOG PS: 0-2
7)Adequate organ functions judged by laboratory tests
8)Life expectancy: over 3 months
9)Written informed consent

Key exclusion criteria

1)Obvious interstitial pneumonia or pulmonary fibrosis by chest CT
2)History of severe allergic reaction
3)Complications such as severe infection or severe comobidities
4)Uncontrolled pleural or pericardial effusion
5)Clinically significant heart disease
6)Uncontrolled hypertension
7)Uncontrolled diabate
8)Active multiple cancer
9)Squamous histology
10)Aparent invasion of main vessels
11)Clinically significant phycological problem
12)History of significant hemoptysis or respiratory bleeding
13)History of GI perfolation
14)non-curable bone fracture or severe injury
15)Planning surgery
16)Significant lung cavitation
17)Bleeding tendency
18)Uncontrolled thromboembolism
19)Prior therapy of EGFR-TKI+bevacizumab
20)History of Afatinib administration
21)Pregnancy
22)Inadequate patients whom physitians considered

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Katakami

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Integrated Oncology

Zip code


Address

2-2, Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-304-5200

Email

katakami@fbri.org


Public contact

Name of contact person

1st name
Middle name
Last name Akito Hata

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Integrated Oncology

Zip code


Address

2-2, Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-304-5200

Homepage URL


Email

a-hata@fbri.org


Sponsor or person

Institute

Foundation for Biomedical Research and Innovation

Institute

Department

Personal name



Funding Source

Organization

Foundation for Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

HANSHIN Oncology Group

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

大阪府立成人病センター呼吸器内科(大阪府)京都桂病院呼吸器内科(京都府)、倉敷中央病院呼吸器内科(岡山県)、神戸市立医療センター中央市民病院呼吸器内科(兵庫県)、神戸市立医療センター西市民病院呼吸器内科(兵庫県)、神戸大学医学部附属病院呼吸器内科(兵庫県)、刀根山病院呼吸器腫瘍内科(大阪府)、先端医療センター総合腫瘍科(兵庫県)、兵庫県立がんセンター呼吸器内科(兵庫県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 07 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete

2017 Year 12 Month 01 Day

Date analysis concluded

2017 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 07 Month 30 Day

Last modified on

2017 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017092


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name