Tarceva Italian Lung Optimization tRial

Sponsor
Fatebenefratelli and Ophthalmic Hospital
Study ID
NCT00637910
Phase
PHASE3
Status
Unknown

Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
  • Docetaxel — DRUG
    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

Study Details

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.

Key Dates

First listed
Mar 18, 2008
Start date
Nov 30, 2007
Status verified
Feb 2012
Primary completion
Feb 29, 2012
Completion
Feb 28, 2013

Study Design

Enrollment
850 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib Arm
  • Active Comparator: Docetaxel Arm

Primary Outcome Measure

Overall Survival [ Time Frame: 12 months after the last patient is randomized ]

Central Contacts

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