1232P - SQUIRE: A randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin (GC) chemotherapy plus necitumumab (IMC-11F8/LY3012211) vs...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Mark Socinski
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors M.A. Socinski1, L. Paz-Ares2, A.V. Luft3, A. Szczesna4, T.E. Ciuleanu5, W. Szafranski6, M. Reck7, B. Balint8, K. Park9, C. Schumann10, F.R. Hirsch11, H. Depenbrock12, S. Nanda13, N. Chouaki14, N. Thatcher15
  • 1Upmc Cancer Pavilion, University of Pittsburgh, 15232 - Pittsburgh/US
  • 2Biomedical Research Institute Of Seville, Hospital Universitario Virgen del Rocio, Seville/ES
  • 3Thoracic Surgery, St. Petersburg Regional Clinic and Hospital, St Petersburg/RU
  • 4Lung Diseases And Tuberculosis, Punjab Treatment Center, Otwok/PL
  • 5University Of Medicine And Pharmacy "iuliu Hatieganu", Institute of Oncology "Ion Chiricuta", Cluj-Napoca/RO
  • 6Department Of Respiratory Medicine, Radom District Hospital, Radom/PL
  • 7Department Of Thoracic Oncology, Lungen Clinic Grosshandorf, Grosshansdorf/DE
  • 8Csongrád County, Hospital of Chest Diseases, Deszk/HU
  • 9Division Of Hematology/oncology, Department Of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR
  • 10Department Of Internal Medicine Ii, Pnemology, Clinic for Pulmonology, Thoracic Oncology, Sleep‐ and Respiratory Critical Care, Hospitals of Kempten‐Oberallgaeu, Ulm/DE
  • 11Cancer Center, University of Colorado, Aurora/US
  • 12Medical Oncology, Lilly Deutschland GmbH, Bad Homburg/DE
  • 13Oncology, ImClone Systems, Branchburg/US
  • 14Medical Oncology, Eli Lilly and Company, Neuilly-sur-Seine/FR
  • 15Medical Oncology, The Christie NHS Foundation Trust, Manchester/GB



EGFR is detectable in most pts with sq-NSCLC tumors. Efficacy and safety of necitumumab (N), a human IgG1 anti-EGFR monoclonal antibody that inhibits ligand-binding and receptor activation, were evaluated in pts with advanced sq-NSCLC tumors.


Pts with stage IV sq-NSCLC were randomized 1:1 to GC (G = 1250 mg/m2 iv, days 1 and 8; C = 75 mg/m2 iv, day 1) plus N (800 mg iv, days 1 and 8) (GC + N arm), or GC alone (GC arm) every 21 days for up to 6 cycles. GC + N pts with no progression continued on N alone until progressive disease or intolerable toxicity. The primary endpoint was overall survival (OS). Progression-free survival and safety were secondary endpoints. Subgroup analyses, evaluating efficacy by age, Eastern Cooperative Oncology Group (ECOG) performance status (PS), gender, and race, were also performed. Planned sample size was 1080 pts, with 90% power and a 2-sided alpha level of 0.05. ClinicalTrials.gov identifier: NCT00981058.


1093 pts were randomized. Baseline characteristics, exposure to chemotherapy, and post-progression anticancer therapy were similar between GC + N and GC arms. The table shows key OS results. The addition of N to GC statistically significantly improved OS (HR = 0.84, p = 0.012), and the safety profile of GC + N was acceptable across subgroups.

OS Results

N mOS, GC + N* N mOS, GC* HR
ITT population 545 11.5 548 9.9 0.84
Age, y
<75 520 11.5 529 9.9 0.84
≥75 25 10.3 19 7.4 0.98
0 164 13.8 180 12.9 0.82
1 332 10.7 320 9.2 0.85
2 49 9.5 47 6.9 0.78
Female 95 13.0 90 11.4 0.88
Male 450 11.1 458 9.7 0.84
Caucasian 457 11.4 456 9.7 0.86
Non-Caucasian 88 12.6 92 11.8 0.78

mOS = median overall survival.

*Data = median (months) estimated by the Kaplan-Meier method.

HR <1 favors GC + N.


This study met its primary endpoint. GC + N demonstrated improved OS, with an acceptable safety profile, across all subgroups.


M.A. Socinski: Steering Committee; L. Paz-Ares: I have provided scientific advice asn received honararium from Lilly; M. Reck: Member of advisory boards (compensated): Lilly, Hoffmann-La Roche, BMS, AstraZeneca, Pfizer, Boehringer Ingelheim, Novartis; K. Park: Advisory Board; Eli Lilly; F.R. Hirsch: Research funding (through University of Colorado) from ImClone - Lilly. Participated in steering committee for the study and advisory borad for Lilly – ImClone; H. Depenbrock: Lilly Employee S. Nanda: I am a lilly employee and I have stock ownership; N. Chouaki: I am a Lilly Employee, I have stock ownership; N. Thatcher: Honoraria :Advsiory Board and Speaker Bureau Member Lilly Imclone. All other authors have declared no conflicts of interest.