BEVERLY: A randomized open-label phase 3 trial comparing bevacizumab + erlotinib vs erlotinib alone as first line treatment of patients with EGFR mutated advanced non squamous non small cell lung cancer

Laborértékek

• EGFR T790M mutation alone or exon 20 insertions as unique mutation • Tumors with a squamous component • Prior chemotherapy or any other medical treatment for advanced NSCLC (previous neoadjuvant or adjuvant chemotherapy is allowed if > 6 months previously) • Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if ≥ 14 days before randomization) • Pregnancy or nursing • Concomitant pathologies or laboratory alterations or concomitant medications use that prevent or contraindicate the use of erlotinib or bevacizumab

• Age ≥18 years • Histologic documentation of primary non squamous non-small cell lung carcinoma • Stage IV or IIIB disease with supraclavear metastatic nodes (according to TNM 7th edition) • Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations, such as exon 21 L861Q, exon 18 G719S, G719A and G719C, exon 20 S768I and V769L). EGFR mutation testing must be performed at participating centres in a certified lab (AIOM-SIAPEC program or other European Quality Assurance [EQA] schemes) • Clinical or radiologic evidence of disease (at least one target or non target lesion according to RECIST 1.1) • ECOG performance status 0 to 2 • Life expectancy > 3 months • Use of an acceptable mean of contraception for men and women of childbearing potential • Written informed consent