NCT05601973

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

A Multicentre Single-arm Phase II Trial of Amivantamab, Lazertinib Plus Bevacizumab in Patients With EGFR-mutant Advanced NSCLC With Progression on Previous Third-generation EGFR-TKI

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Amivantamab	Amivantamab is given at a fixed dose of 1750 mg (if baseline body weight is \<80 kg) or 2100 mg (if baseline body weight is ≥80 kg), i.v. every 3 weeks, until disease progression, or intolerable toxicity.
DRUG	Lazertinib	Lazertinib is given at a dose of 240 mg, orally, once daily. Treatment with lazertinib continues until disease progression or intolerable toxicities.
DRUG	Zirabev	Bevacizumab (Zirabev®) is administered at a dose of 15mg/kg, i.v. every 3 weeks, until disease progression, or intolerable toxicity.

Timeline

• Start date: 2023-03-27
• Primary completion: 2024-08-24
• Completion: 2026-09-30
• First posted: 2022-11-01
• Last updated: 2026-01-21

Locations

18 sites across 6 countries: France, Italy, Netherlands, Spain, Switzerland, United Kingdom