Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Disease Progression

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Lazertinib

Amivantamab-vmjw

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Amivantamab (fixed dose of 1750 mg (or 2100 mg, i.v. every 3 weeks, until disease progression, or intolerable toxicity) PLUS Lazertinib (240 mg, orally, once daily, until disease progression or intolerable toxicities) PLUS Bevacizumab (Zirabev® is administered at a dose of 15mg/kg, i.v. every 3 weeks, until disease progression, or intolerable toxicity).

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.

Amivantamab

Lazertinib is given at a dose of 240 mg, orally, once daily. Treatment with lazertinib continues until disease progression or intolerable toxicities.

Bevacizumab (Zirabev®) is administered at a dose of 15mg/kg, i.v. every 3 weeks, until disease progression, or intolerable toxicity.

Zirabev

Heidi Roschitzki, PhD

Susanne Roux

Youssef Oulkhouir, MD

Nicolas Cloarec, MD

Maurice Perol, MD

Pier Luigi Piovano, MD

Giulio Metro, MD

Joop de Langen, MD

Ross Soo, MD

Joaquín Mosquera Martínez, MD

Bartomeu Massuti, MD

Marc Cucurull Salamero, MD

Patricia Iranzo, MD

Mª Angeles Sala, MD

Ernest Nadal, MD

Manuel DÓMINE, MD

Rafael López Castro, MD

Patrizia Frösch, MD

Ferdinando MD Cerciello, MD

Adrienne Bettini

Alfredo Addeo, MD

Martin Früh, MD

Sanjay Popat, MD

Ross Soo, MD FRACP

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.

AMAZE-lung: 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

The primary endpoint to assess the efficacy of amivantamab and bevacizumab added to continued treatment with a third-generation EGFR-TKI (osimertinib or lazertinib) is the objective response rate (ORR), investigator assessed, at 12 weeks according to RECIST v1.1. ORR is defined as the rate of patients, among all enrolled patients, that achieve a best overall response \[complete response (CR) or partial response (PR)\] across all post-enrolment tumour-assessment time-points.

Secondary endpoint: Duration of response (DoR)

Secondary endpoint: Progression-free survival (PFS) according to RECIST v1.1

Secondary endpoint: Disease control rate (DCR) according to RECIST v1.1 patients, among all enrolled patients, that achieve CR or PR or disease stabilisation at 12 weeks.

Secondary endpoint: Overall survival (OS)

Secondary endpoint: Safety and tolerability (CTCAE v5.0)

Janssen Pharmaceuticals

ETOP IBCSG Partners Foundation

Spots Global Cancer Trial Database for zirabev

Every month we try and update this database with for zirabev cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zirabev

Every month we try and update this database with for zirabev cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zirabev cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.