UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002795 |
|---|---|
| Receipt number | R000003398 |
| Scientific Title | Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903) |
| Date of disclosure of the study information | 2009/11/25 |
| Last modified on | 2012/11/28 14:24:28 |
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Basic information
Public title
Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)
Acronym
Erlotonib in pre-treated NSCLC with wild type EGFR
Scientific Title
Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)
Scientific Title:Acronym
Erlotonib in pre-treated NSCLC with wild type EGFR
Region
| Japan |
Condition
Condition
Pre-treated non-small cell lung cancer with wild type EGFR and occurred in never or light smoker
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of erlotinib monotherapy for previously treated non-small cell lung cancer (NSCLC) harboring wild type EGFR and occurred in never or light smoker
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Disease control rate, progression free survival, overall survival, and safety. The biomarkers that predict the efficacy will be searched.
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
Daily administration of erlotinib
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 proved NSCLC
2)Stage IIIB, IV disease, or relapsed diseases after surgery that lack indication of surgery or radiotherapy
3)A tumor specimen is available
4)Wild type EGFR
5)Measureable region evaluable according to the RECIST
6)Number of previous chemotherapy regimens are 1 or 2
7)No previous EGFR-TKI treatment
8)Never or light smoker less than 10 pack year
9)Elder than 20 years of age
10)ECOG performance status of 0-2
11)Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment
12)Adequate organ functions (WBC => 3,000 /mm3, Neutrophil =>1,000 /mm3, Platelet => 100,000 /mm3, hemoglobin concentration => 9.0 g/dl, AST or ALT <= ULN x 2, Total bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, SpO2 => 95%)
13)Life expectancy of at least 3 months
14)Sufficient time has elapsed after the previous treatment
(1)More than 3 weeks after last day of chemotherapy
(2)More than 12 weeks after thoracic radiation
(3)More than 2 weeks after surgical treatment
15)Written informed consent
Key exclusion criteria
1)Presence of active interstitial pneumonia, radiation pneumonia, pneumoconiosis, or drug induced pneumonia
2)Uncontrolled pleural effusion, ascites, or pericardial effusion
3)Presence of infection that necessitates treatments with intravenous antibiotics
4)History of HER-related drug treatment
5)T790M mutation
6)Symptomatic eye disease
7)Pregnant patients
8)Symptomatic brain metastases
9)Other active malignancies
10)Poorly controlled diabetes mellitus
11)Severe and uncontrolled complication
12)Current smoker
13)Evaluated to be ineligible by a physician for other reasons
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Saijo |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
Zaifumachi 5, Hirosaki, 036-8562, Japan
TEL
81-172-39-5345
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Saijo |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
Zaifumachi 5, Hirosaki, 036-8562, Japan
TEL
81-172-39-5345
Homepage URL
yasosj@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
North East Japan Study Group /The Tokyo
Cooperative Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 24 | Day |
Last modified on
| 2012 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003398
