drugset / Trial / NCT05601973

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI

NCT05601973

Phase 2 Active not recruiting 60 enrolled ETOP IBCSG Partners Foundation Janssen Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

Summary

AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial. In addition, the safety of the treatment combination will be evaluated.

Timeline

Start
2023-03-27
Primary completion
2024-08-24
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody 1750 mg Intravenous
Subject Amivantamab Monoclonal antibody 2100 mg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Lazertinib Small molecule 240 mg Oral