NCT05263947

Bevacizumab Combined With Double Doses of Icotinib in Advanced NSCLC Patients With EGFR L858R Mutation

Efficacy and Safety of Bevacizumab Combined With Double Doses of Icotinib in Advanced Non-squamous Non-small Cell Lung Cancer With EGFR Exon 21 L858R Mutation: a Prospective, Single-arm, Phase 2 Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, single-center, phase II trial designed to evaluate the efficacy and safety of bevacizumab combined with a double dose of icotinib as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) harboring an EGFR Exon 21 L858R mutation. Patients will receive bevacizumab and icotinib (250 mg, administered orally three times per day ) until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity profile. The hypothesis is that the combination therapy will provide improved outcomes for this patient population, which typically has a poorer response to standard EGFR-TKI therapy.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Bevacizumab
• Tyrosine Kinase Inhibitor
• EGFR L858R

Interventions

Type	Name	Description
DRUG	Bevacizumab	15 mg/kg, intravenous infusion, every three weeks
DRUG	Icotinib	Oral 250 mg, three times per day

Timeline

• Start date: 2022-01-30
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-03-03
• Last updated: 2026-02-24

Locations

1 site across 1 country: China