UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Nobuyuki Katakami
Organization	Kobe City Mecical Center General Hospital
Division name	Department of Medical Oncology
Address	1-1, 2-chome, Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Email	nkatakami@kcho.jp

Public contact
Name of contact person	Akito Hata
Organization	Kobe City Mecical Center General Hospital
Division name	Department of Medical Oncology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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