NCT00637910

Tarceva Italian Lung Optimization tRial

Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Fatebenefratelli and Ophthalmic Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Erlotinib	Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
DRUG	Docetaxel	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

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-02-01
• Completion: 2013-02-01
• First posted: 2008-03-18
• Last updated: 2012-02-24

Locations

105 sites across 1 country: Italy