UMIN-CTR Clinical Trial

Basic information
Public title	Afatinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring active EGFR mutations : an open-label, randomized, multicenter, phase II study
Acronym	Afatinib vs Afatinib+Bevacizumab
Scientific Title	Afatinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring active EGFR mutations : an open-label, randomized, multicenter, phase II study
Scientific Title:Acronym	Afatinib vs Afatinib+Bevacizumab
Region	Japan

Condition
Condition	Non-squamous non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We compare combination therapy of afatinib and bevacizumab with afatinib alone for EGFR mutant non-squamous non-small cell lung cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	Overall survival, Response rate, Disease control rate, Relative dose intensity, Quality of life, Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	afatinib 30 mg/day and bevacizumab 15 mg/kg every 3 weeks, until disease progression or unacceptable toxicity
Interventions/Control_2	afatinib 40 mg/day, until disease progression or unacceptable toxicity
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) Non-squamous non-small cell lung cancer 2) EGFR exon19 deletion or L858R 3) stage IIIB or IV or recurrence 4) chemotherapy naive 5) ECOG PS 0 or 1 6) With measurable target lesion or unmeasurable lesion as per RECIST ver1.1 7) With adequate organ function 8) Provided written informed consent
Key exclusion criteria	1) EGFR exon20 T790M 2) Symptomatic brain metastasis 3) Meningitis 4) Other cancers 5) Hemoptysis 6) Hemorrhagic tendency (coagulation disorder etc.) 7) Invasion to measure artery or vessel 8) Invasion to mucosa of bronchus 9) Pleural effusion, ascites or pericardial effusion requiring drainage 10) With severe complication (SVC symdrome, interstinal neumonia etc.) 11) History of serious drug allergies 12) Pregnancy, breast feeding, or hesitation in contraception 13) Other conditions not suitable for this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuyuki Kiura
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine and Allergy
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7227
Email	kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Ninomiya
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine and Allergy
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7227
Homepage URL
Email	tninomiya5@okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Boehringer Ingerheim
Organization
Division
Category of Funding Organization	Profit organization
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 18 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	Terminated
Date of protocol fixation	2017 Year 06 Month 18 Day
Date of IRB	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 06 Month 20 Day
Last follow-up date	2019 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 21 Day
Last modified on	2019 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031396