Lung Cancer 85 (2014) 415–419 Contents lists available at ScienceDirect Lung Cancer jou rn al hom epage: www.elsevier.com/locate/lungcan 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 J.B. Auliac a,∗ , C. Chouaid b , L. Greiller c , I. Monnet d , H. Le Caer e , L. Falchero f , R. Corre g , R. Descourt h , S. Bota i , H. Berard j , R. Schott k , A. Bizieux l , P. Fournel m , A. Labrunie n , B. Marin n , A. Vergnenegre o , the GFPC team a Department of Pneumology, Quesnay Hospital, Mantes La Jolie, France b Department of Pneumology, Saint Antoine Hospital, Paris, France c Multidisciplinary Oncology and Therapeutic Innovations, AP-HM, Marseilles, France d Service de pneumologie, CHI, Creteil, France e CH de Draguignan, Draguignan, France f CH Villefranche Sur Saone, Villefranche-sur-Saone, France g Pneumology, CHU Pontchaillou, Rennes, France h CHU Morvan, Brest, France i Hôpital Charles Nicolle, Rouen, France j Pneumology, HIA, Toulon, France k Centre Paul Strauss, Strasbourg, France l CHD La Roche Sur Yon, La Roche Sur Yon, France m Institut de Cancérologie de la Loire, Saint Priest En Jarez, France n CEBIMER, CHU limoges, Limoges, France o CHU Limoges, Limoges, France a r t i c l e i n f o Article history: Received 11 April 2014 Received in revised form 7 July 2014 Accepted 10 July 2014 Keywords: Erlotinib Docetaxel Non-small-cell lung cancer Second-line Epithelial growth factor wild-type status a b s t r a c t Background: Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer (NSCLC), but preliminary studies sug- gest that sequential administration might be effective. Objective: To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC. Methods: In an open-label phase II trial, patients with advanced NSCLC, EGFR wild-type or unknown, PS 0-2, in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d (day 2–16) + docetaxel (75 mg/m 2 d1) (arm ED) or docetaxel (75 mg/m 2 d1) alone (arm D) (21- day cycle). The primary endpoint was the progression-free survival rate at 15 weeks (PFS 15). Secondary endpoints included PFS, overall survival (OS), the overall response rate (ORR) and tolerability. Based on a Simon optimal two-stage design, the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages. Results: 147 patients were randomized (median age: 60 ± 8 years, PS 0/1/2: 44/83/20 patients; males: 78%). The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D, respectively, median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months. Conclusion: Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status. © 2014 Elsevier Ireland Ltd. All rights reserved. ∗ Corresponding author. Tel.: +33 0 1 34 97 42 88; fax: +33 0 1 34 97 42 15. E-mail address: jb.auliac@ch-mantes-la-jolie.fr (J.B. Auliac). 1. Introduction Non-small-cell lung cancer (NSCLC) accounts for 80% of lung cancers, and most patients already have advanced or metastatic http://dx.doi.org/10.1016/j.lungcan.2014.07.006 0169-5002/© 2014 Elsevier Ireland Ltd. All rights reserved.