UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008398 |
|---|---|
| Receipt number | R000009880 |
| Scientific Title | Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type |
| Date of disclosure of the study information | 2012/07/11 |
| Last modified on | 2015/01/13 11:38:42 |
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Basic information
Public title
Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type
Acronym
Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type
Scientific Title
Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type
Scientific Title:Acronym
Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type
Region
| Japan |
Condition
Condition
advanced or recurrent non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Erlotinib in previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response Rate
Overall survival
Safety
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
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 proven non-squamous non small cell lung cancer
2)Patients with EGFR wild type and KRAS wild type
3)Patients with Stage3B/4
4)Patients who have previously treated with one or two chemotherapy
5)Patients who has measurable by RECIST criteria
6)Patients aged 20 years or older
7)ECOG Performance status 0-2
8)Adequate organ function
9)Life expectancy more than 3 months
10)Signed written informed consent
Key exclusion criteria
1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis
2)Cases with past history of administration of HER related agents
3)4) Patients having EGFR mutation (exon 18,19,20,21)
4)Patients with gastrointestinal disorders
5)Patients with active opthalmological disease
6)Patients with spinal cord compression syndrome
7)Patients with symptomatic brain
8)Patients with active severe infections
9)Patients with active cardiac disease
10)Patients with severe clinical symptom
11)Patients active concomitant malignancy
12)Severe psychological disease
13)Pregnant or breast-feeding females or those who declined contraception
14)Inappropriate patients for this study judged by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Sunaga |
Organization
Gunma Uninersity Hospital
Division name
Zip code
Address
3-39-15, Shouwa-town, Maebashi-city, Gunma
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gunma Uninersity Hospital
Division name
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Gunma Uninersity Hospital
Institute
Department
Personal name
Funding Source
Organization
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
| 2012 | Year | 07 | Month | 11 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 10 | Day |
Last modified on
| 2015 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009880
