UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027432 |
|---|---|
| Receipt number | 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 11:49:03 |
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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
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
tninomiya5@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031396
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