Non-squamous Non-small Cell Lung Cancer
Conditions
Brief summary
To test whether the combination of bevacizumab and erlotinib can prolong investigator assessed (IA-PFS) and blinded independent centrally-reviewed progression-free survival (BICR-PFS) as compared with erlotinib alone as first-line treatment in patients with NSCLC with activating mutation of EGFR. Note: CT (or other pertinent) scans performed at baseline and during follow-up will be collected and reviewed by an independent central panel of radiologists who will be blinded to the assigned tr
Detailed description
• To compare the two arms in terms of o overall survival o quality of life (EORTC C30 + LC13) o centrally reviewed objective response rate (RECIST v.1.1) o investigator assessed objective response rate (RECIST v.1.1) o adverse events (CTCAE 4.03 version) • To test whether an interaction exists between treatment arms and type of EGFR mutation (exon 19del vs exon 21 L858R vs other) • To explore other possible predictive factors and their interaction with treatment arms • To explore pro
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test whether the combination of bevacizumab and erlotinib can prolong investigator assessed (IA-PFS) and blinded independent centrally-reviewed progression-free survival (BICR-PFS) as compared with erlotinib alone as first-line treatment in patients with NSCLC with activating mutation of EGFR. Note: CT (or other pertinent) scans performed at baseline and during follow-up will be collected and reviewed by an independent central panel of radiologists who will be blinded to the assigned tr | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare the two arms in terms of o overall survival o quality of life (EORTC C30 + LC13) o centrally reviewed objective response rate (RECIST v.1.1) o investigator assessed objective response rate (RECIST v.1.1) o adverse events (CTCAE 4.03 version) • To test whether an interaction exists between treatment arms and type of EGFR mutation (exon 19del vs exon 21 L858R vs other) • To explore other possible predictive factors and their interaction with treatment arms • To explore pro | — |
Countries
Italy