Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer

Sponsor
University Hospital, Limoges
Study ID
NCT01350817
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib + docetaxel — DRUG
    docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
  • Docetaxel — DRUG
    docetaxel :75 mg/m² IV day 1 every 3 weeks.

Study Details

This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks. The anticipated time on study treatment is until disease progression. Target sample size is 156. The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .

Key Dates

First listed
May 10, 2011
Start date
Jun 30, 2011
Status verified
Apr 2015
Primary completion
Mar 31, 2013
Completion
Jan 31, 2014

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Docetaxel
  • Experimental: Erlotinib

Primary Outcome Measure

Progression Free Survival at 15 Weeks. [ Time Frame: at 15 weeks ]

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