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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027432
Receipt No. R000031396
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
Date of disclosure of the study information 2017/06/18
Last modified on 2019/06/06

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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

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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