The purpose of this study is to test whether the combination of bevacizumab and erlotinib can prolong progression free survival as compared with erlotinib alone as first-line treatment in patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR.
The co-primary objectives are to assess investigator-assess, and blinded independent centrally-reviewed progression-free survival .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
given orally 150 mg daily
15 mg/kg intravenously every 21 days.
progression free survival
as determined by investigator
Time frame: up to 2 years
progression free survival
as determined by an independent central review board blinded to study treatment
Time frame: up to 2 years
overall survival
Time frame: 1 year
changes in quality of life scores from baseline
Time frame: up to 2 years
number of patients with complete and partial responses , investigator assessed
Time frame: 6 months
number of patients with complete and partial responses , centrally reviewed
Time frame: 6 months
worst grade toxicity per patient
Time frame: up to one year
progression free survival according to type of EGFR mutation (exon 19del, exon 21L858R, other)
Time frame: 2 years
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Ospedale Ramazzini, Day Hospital Oncologico
Carpi, MO, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy
Ospedale di Prato
Prato, PO, Italy
Ospedale S. Chiara
Trento, TN, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy
A.S.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
A.O. S. Giuseppe Moscati
Avellino, Italy
Centro Riferimento Oncologico
Aviano, Italy
AO G. Rummo
Benevento, Italy
Ospedale Senatore Antonio Perrino
Brindisi, Italy
...and 45 more locations