UMIN ID: UMIN000002453
Registered date:01/04/2010
2nd-line Tarceva+ALIMTA for EGFR mutation negative non-small, non-squamous lung cancer (TALIMTA STUDY)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | non-sq NSCLC |
Date of first enrollment | 2009/10/01 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | chemotherapy with erlotinib and pemetrexed |
Outcome(s)
Primary Outcome | disease control rate |
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Secondary Outcome | overall survival, progression-free survival, 1-year survival, safety |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Respiratory Medicine, Kyoto University Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | |
Affiliation | Kyoto University Hospital Respiratory Medicine |
scientific contact | |
Name | Young Hak Kim |
Address | 54 Shogoin-Kawaharacho Sakyo-ku Kyoto Japan |
Telephone | |
Affiliation | Kyoto University Hospital Respiratory Medicine |