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

Summary

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 .

Timeline

Start

2011-06

Primary completion

2013-03

Completion

2014-01

Outcome

Missed primary endpoint

paper The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 PMID 25082565 ↗

Publications

• Results Auliac JB, Chouaid C, Greillier L, Monnet I, Le Caer H, Falchero L, Corre R, Descourt R, Bota S, Berard H, Schott R, Bizieux A, Fournel P, Labrunie A, Marin B, Vergnenegre A; GFPC team. Randomized open-label non-comparative multicenter phase II trial of sequential erlotinib and docetaxel versus docetaxel alone in patients with non-small-cell lung cancer after failure of first-line chemotherapy: GFPC 10.02 study. Lung Cancer. 2014 Sep;85(3):415-9. doi: 10.1016/j.lungcan.2014.07.006. Epub 2014 Jul 17.

Drugs

Indications