A randomised phase II trial of osimertinib and bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M

BOOSTER: Osimertinib and Bevacizumab versus Osimertinib alOne as Second-line Treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M

First-generation EGFR tyrosine kinase inhibitors provide a significant clinical benefit for patients with advanced EGFR-mutant NSCLC. However, most patients ultimately develop disease progression, driven by the acquisition of a second T790M EGFR TKI resistance mutation.

Osimertinib (AZD9291) is an irreversible third-generation tyrosine kinase inhibitor of both EGFRm-sensitizing and T790M resistance mutants.

Bevacizumab is a humanized antibody targeting the vascular endothelial growth factor VEGF, which plays an important role in tumour angiogenesis.

A combination treatment that target both tumour cells and tumour microenvironment (such as angiogenesis) may be a promising strategy for further improving efficacy outcomes in patients with EGFRm (exon 19 deletion or exon 21 L858R) NSCLC following progression on EGFR TKI therapy and other lines of therapy.

The aim of the BOOSTER trial is to assess the efficacy of osimertinib plus bevacizumab versus osimertinib alone for patients with locally advanced or metastatic (stage IIIb-IVb) EGFRm NSCLC with a T790M resistance mutation at progression on prior EGFR TKI therapy.

Trial Scheme

Trial Design for Website

 

Primary endpoint: Progression-free survival
Secondary endpoints:  

Objective response

Disease control

Overall survival

Adverse events

Target Sample Size: 153 Patients 
Protocol Release: December 2016

Trial Organisation

Trial Chairs: Solange Peters and Rolf Stahel
Trial Co-Chairs: Ross Soo and Ji-Youn Han
Sponsor: ETOP
Coordinating Group: ETOP
Participating Groups: Cancer Trials Ireland, SAKK and SLCG  
Participating Countries:   Ireland, Netherlands, Spain, Switzerland, Korea and Singapore
Registrations:

EudraCT number: 2016-002029-12

ClinicalTrials.gov: NCT03133546

Contact:

Lucie Mlejnkova (Trial Manager)

Tel: +41 31 511 94 45

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European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00