UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011791 |
|---|---|
| Receipt number | R000013786 |
| Scientific Title | A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001 |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2013/09/18 13:54:30 |
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Basic information
Public title
A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001
Acronym
A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001
Scientific Title
A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001
Scientific Title:Acronym
A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate efficacy and safety of second-line Erlotinib and Bevacizumab combination chemotherapy to Intended for patients of treatment failure in first-line Bevacizumab platinum combination chemotherapy with StageIIIB/IV non- squamous 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
PFS at 3months after randomized
Key secondary outcomes
Response rate, Disease Control Rate, Progression-free survival, Overall survival, Safety, Biomarker
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
Erlotinib 150mg/day
Bevacizumab 15mg/kg q3w
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)stage IIIB/IV or recurrence and histologically or cytologically confirmed non-squamous non-small cell lung cancer
2)history of 4 courses or more bevacizumab plus platinum doublet
3)known no active EGFR gene mutation or Unknown
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*whole-brain irradiation(WBRT):2weeks
*stereotactic irradiation(SRI):1day
*irradiation of bone metastases:1day
*palliative radiotherapy:2weeks
*operation(surgery without lobectomy):4weeks
*operation(endoscopic surgery without lobectomy):2weeks
*biopsy with incision, port custody, and treatment to injury:1week
*pleurodesis:2weeks
*chest drainage:1weeks
8)adequate bone marrow,liver,and renal functions
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0g/dL
*AST and ALT, x 2.5 of upper limit of
normal (ULN) or less
*Total bilirubin <= 1.5mg/dL
*Serum creatinin, x 1.5mg/dL of ULN or less
*SpO2(Room air) >=90%
* PT-INR < 1.5
*Protein urea <= 1+
9)a life expectancy of 3 months or more
10)written informed consent
Key exclusion criteria
1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known EGFR-TKI resistance gene mutation positive
3)known ALK gene translocation positive
4)history of erlotinib or gefitinib treatment
5)inable of oral drug administration
6)current or previous histoty of hemoptysis(2.5ml)due to NSCLC
7)Risk of hemoptysis patients after thoracic radiation therapy is expected
8)With great vessel invasion
9)1cm or longer cavity in tumor
10)current or previous (within the last 1 year)history of GI perforation
11)history of myocardial infarction and cerebral infarction
12)planned surgery within study term
13)uncontrolled heypertension
14)symptomatic brain metastasis
15)history of drug allergy
16)massive,pleural effusion or ascites
17)uncontrolled infection or serious medical complications
18)active concomitant malignancy
19)mental disorder
20)pregnant or or lactating women or those who declined contraception
21)those judged not suitable by the attending physician
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Takao |
Organization
Itabashi Chuo Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-12-7 Azusawa, Itabashi, Tokyo 174-0051
TEL
03-3967-0572
respiratory_itabashichuo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Takao |
Organization
Itabashi Chuo Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-12-7 Azusawa, Itabashi, Tokyo 174-0051
TEL
03-3967-0572
Homepage URL
respiratory_itabashichuo@yahoo.co.jp
Sponsor or person
Institute
Itabashi Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Itabashi Chuo Medical Center
Organization
Division
Category of Funding Organization
Self funding
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
板橋中央総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2013 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013786
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