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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516843-15-00
Enrollment
200
Registered
2024-11-18
Start date
2015-11-23
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-squamous Non-small Cell Lung Cancer

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

DRUGBEVACIZUMAB
DRUGERLOTINIB

Sponsors

IRCCS Istituto Nazionale Tumori Fondazione Pascale
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026