♦
Objetivo Primario: Supervivencia Global (SG): Poder Estadístico 80% (eventos 844) HR
0,80
Randomization stratified by:
ECOG PS (0-1 vs. 2) and geographic region (North America, Europe, and Australia;
vs. South America, South Africa, and India; vs. Eastern Asia)
PD
CR
PR
SD
PD
Neci + Gem-Cis q3w (N=545)
Necitumumab 800 mg D1, D8
Gemcitabine 1250 mg/m², D1, D8
Cisplatin 75 mg/m², D1
PD
Maximum of 6 cycles
Screening
Entry criteria:
First-line
Stage IV
squamous
NSCLC
3,4
ECOG PS 0-2
Neci q3w
800 mg D1, D8
Gem-Cis q3w (N=548)
Gemcitabine 1250 mg/m², D1, D8
Cisplatin 75 mg/m², D1
R
1. Thatcher N et al. Presented at ASCO 2014. Abstract 8008
2. Reck M et al. Presented at ESMO 2014. Abstract 1267
3. Edge SB et al.
AJCC Cancer Staging Manual
, 2010
4. Sobin LH et al.
TNM Classification of Malignant Tumors
, 2010
Estudio SQUIRE: CPNM-Escamoso
(NECI=NECITUMUMAB)
