UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002453 |
|---|---|
| Receipt number | R000003004 |
| Scientific Title | 2nd-line Tarceva+ALIMTA for EGFR mutation negative non-small, non-squamous lung cancer (TALIMTA STUDY) |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2014/08/09 14:41:56 |
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Basic information
Public title
2nd-line Tarceva+ALIMTA for EGFR mutation negative non-small, non-squamous lung cancer (TALIMTA STUDY)
Acronym
2nd-line Tarceva+ALIMTA for EGFR mutation negative non-small, non-squamous lung cancer (TALIMTA STUDY)
Scientific Title
2nd-line Tarceva+ALIMTA for EGFR mutation negative non-small, non-squamous lung cancer (TALIMTA STUDY)
Scientific Title:Acronym
2nd-line Tarceva+ALIMTA for EGFR mutation negative non-small, non-squamous lung cancer (TALIMTA STUDY)
Region
| Japan |
Condition
Condition
non-sq NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of 2nd-line chemotherapy with Erlotinib and pemetrexed in
patients with non^sq NSCLC who do not have active EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
disease control rate
Key secondary outcomes
overall survival, progression-free survival, 1-year survival, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy with erlotinib and pemetrexed
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-sq NSCLC
2)Stage IIIb or IV
3)one previous chemotherapy
4)no EGFR mutation in exon 18-21
5)mesurable lesion
6)age: ≥75
7)ECOG PS 0-1
8)normal organ function
9)written informed consesnt
Key exclusion criteria
1)previous chemotherapy with erlotinib, gefitinib, or pemetrexed
2)interstitial pneumoia/active lung fibrosis on chest x-ray
3)massive or uncontrolable pleural effusion
4)symptomatic brain metastasis
5)active concomitant malignancy
6)severe comorbidity
7)pregnant or lactating woman
8)history of severe drug allergy
9)psychiatry disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Young Hak Kim |
Organization
Kyoto University Hospital
Division name
Respiratory Medicine
Zip code
Address
54 Shogoin-Kawaharacho Sakyo-ku Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Respiratory Medicine, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding 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
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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 | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | 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
| 2009 | Year | 09 | Month | 05 | Day |
Last modified on
| 2014 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003004
