UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030545 |
|---|---|
| Receipt number | 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 18:56:58 |
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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
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
akitohata@hotmail.com
Sponsor or person
Institute
Hanshin Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034873
