Tarceva Italian Lung Optimization tRial (TAILOR)
The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.
Non Small Cell Lung Cancer (NSCLC)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial|
- Overall Survival [ Time Frame: 12 months after the last patient is randomized ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: with 4 years and 12 months after the last patient is randomized ] [ Designated as safety issue: No ]
- Response assessed with RECIST criteria [ Time Frame: within 4 years ] [ Designated as safety issue: No ]
- Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires [ Time Frame: within 4 years ] [ Designated as safety issue: No ]
- Toxicity, graded according to the NCI-CTAE version 3.0 [ Time Frame: within 4 years ] [ Designated as safety issue: Yes ]
- Frequency and nature of serious adverse reactions [ Time Frame: within 4 years ] [ Designated as safety issue: Yes ]
- Premature withdrawals [ Time Frame: within 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: Erlotinib Arm||
Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
Other Name: Tarceva
|Active Comparator: Docetaxel Arm||
Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops
Other Name: Taxotere
Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients.
Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome.
For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.
|Contact: Marina C Garassino, MD||+39 firstname.lastname@example.org|
|Contact: Serena Girelli, Biologist||+39 email@example.com|
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|Principal Investigator:||Alberto Scanni, MD||Fatebenefratelli and Ophthalmic Hospital|