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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030545
Receipt No. R000034873
Scientific Title Afatinib plus Bevacizumab Combination after osimertinib failure for aDvanced EGFR-mutant non-small cell lung cancer: a multicenter prospective single arm phase II study (ABCD-study)
Date of disclosure of the study information 2018/01/01
Last modified on 2018/01/30

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Basic information
Public title Afatinib plus Bevacizumab Combination after osimertinib failure for aDvanced EGFR-mutant non-small cell lung cancer: a multicenter prospective single arm phase II study (ABCD-study)
Acronym Afatinib plus Bevacizumab after Osimertinib failure
Scientific Title Afatinib plus Bevacizumab Combination after osimertinib failure for aDvanced EGFR-mutant non-small cell lung cancer: a multicenter prospective single arm phase II study (ABCD-study)
Scientific Title:Acronym Afatinib plus Bevacizumab after Osimertinib failure
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Afatinib plus Bevacizumab after Osimertinib failure in advanced EGFR-mutant non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
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 Afatinib (30 mg or 40 mg/day, day 1-21, orally) and Bevacizumab (15 mg/kg, day 1, intravenously) are administered every 3 weeks until progression.

Histological and liquid rebiopsy are mandatory before initiating the trial treatment using Afatinib plus Bevacizumab
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-small cell lung cancer (except squamous carcinoma)
2) EGFR-mutation positive
3) After Osimertinib failure, based on Jackman criteria
4) Receipt of histological rebiopsy after Osimertinib failure
5) After 4 weeks from completion of chest radiation
6) Aged older than 20
7) PS (ECOG) 0 or 1
8) Presence of measurable lesions by RECIST ver.1.1
9) Adequate organ functions
10) Life expectancy longer than 3 months
11) Written informed consent
Key exclusion criteria 1) Interstitial lung disease or pulmonary fibrosis
2) Symptomatic central nervous system metastases
3) History of severe allergic reaction to drugs
4) Severe infection or comorbidities
5) Massive or uncontrolled pleural, abdominal, or cardiac effusion
6) Clinically significant arythmia, angina, or heart failure
7) Uncontrolled hypertension
8) Uncntrolled diabetes
9) Active double cancers
10) Hitologically dominant of squanous carcinoma
11) Severe phycological disease
12) Massive hemoptysis
13) Gastrointestinal perfolation within 1 year
14) Incurable bone fracture
15) Planning major surgery during trial
16) Bleeding tendency
17) Uncontrolled thrombosis
18) Receipt of EGFR-TKIs other than Osimertinib or immunotherapy
19) Pregnancy
20) Patients whom doctos in charge judge unproper
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Kobe City Mecical Center General Hospital
Division name Department of Medical Oncology
Zip code
Address 1-1, 2-chome, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-302-4321
Email nkatakami@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akito Hata
Organization Kobe City Mecical Center General Hospital
Division name Department of Medical Oncology
Zip code
Address 1-1, 2-chome, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-302-4321
Homepage URL
Email akitohata@hotmail.com

Sponsor
Institute Hanshin Oncology Group
Institute
Department

Funding Source
Organization Boehringer Ingelheim Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 明石医療センター(兵庫県)、大阪国際がんセンター(大阪府)、関西医科大学付属病院(大阪府)、京都桂病院(京都府)、倉敷中央病院(岡山県)、神戸市立医療センター西市民病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、神戸大学医学部付属病院(兵庫県)、宝塚市立病院(兵庫県)、刀根山病院(大阪府)、兵庫県立がんセンター(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 01 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
2017 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 24 Day
Last modified on
2018 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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