ORIGINAL RESEARCH Second-line therapy with gefitinib in combination with docetaxel for advanced non-small cell lung cancer: a phase II randomized study G. Robinet & F. Barlesi & P. Fournel & H. Berard & R. Corre & A. Vergnenegre & L. Falchero & P-J. Souquet & A. Tisseron-Carrasco & C. Chouaid Received: 9 October 2006 / Revised: 29 January 2007 / Accepted: 31 January 2007 / Published online: 27 February 2007 # Springer-Verlag 2007 Abstract This randomized, open-label, parallel-group, phase II study evaluated the efficacy and safety of gefitinib and docetaxel in combination, as second-line therapy for advanced or metastatic non-small cell lung cancer (NSCLC). Eighty-nine patients who had failed first-line, platinum-based chemotherapy were randomly assigned to gefitinib (250 mg/day orally) in combination with docetaxel (75 mg/m 2 every 3 weeks) or single-agent docetaxel (75 mg/m 2 every 3 weeks). Objective response rates were 6.8% with gefitinib plus docetaxel and 9.1% with docetaxel alone. Disease control was experienced by a higher proportion of patients receiving gefitinib plus docetaxel (59.1%) versus docetaxel alone (34.1%). Median pro- gression-free and overall survival appeared to be longer with gefitinib plus docetaxel (3.9 months [95% CI:2.3– 5.4] and 7.6 months [95% CI:5.4–10.4], respectively) than with docetaxel alone (2.1 months [95% CI:2.1–3.7] and 6.2 months [95% CI:5.2–7.2], respectively). The most common non-hematological adverse events were diarrhea, alopecia, rash and dry skin in the combination arm, and vomiting and asthenia with docetaxel alone. Gefitinib and docetaxel combination therapy has anti- tumor activity and may be a feasible treatment option in patients with advanced NSCLC who have failed plati- num-based chemotherapy. Keywords Epidermal growth factor receptor . Epidermal growth factor receptor-tyrosine kinase inhibitor . Gefitinib . IRESSA . Non-small cell lung cancer Targ Oncol (2007) 2:63–71 DOI 10.1007/s11523-007-0042-9 G. Robinet (*) Institut de Cancérologie et d’Hématologie, CHU Morvan, 29200 Brest, France e-mail: gilles.robinet@chu-brest.fr F. Barlesi Hôpital Sainte-Marguerite, CHU Marseille, Marseille, France P. Fournel Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne, France H. Berard Hôpital Sainte-Anne, Toulon, France R. Corre Hôpital Pontchaillou, Rennes, France A. Vergnenegre Hôpital du Cluzeau, Limoges, France L. Falchero Centre Hospitalier, Villefranche sur Saône, France P.-J. Souquet CHU Lyon-Sud, Lyon, France A. Tisseron-Carrasco AstraZeneca, Rueil, France C. Chouaid Hôpital Saint Antoine, Paris, France