drugset / Trial / NCT05263947

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

NCT05263947

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-01-30
Primary completion
2023-12-30
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Icotinib Small molecule 250 mg Oral