A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC

ALERT-lung: ALEctinib for the treatment of pretreated RET-rearranged advanced non-small cell lung cancer

The RET gene encodes for a transmembrane receptor with tyrosine kinase activity. It is involved in cell proliferation, migration, differentiation, and in neuronal navigation. RET rearrangements occur in 1%-2% of patients with adenocarcinoma. Alectinib is a highly selective next generation ALK inhibitor that has demonstrated potent anti-tumour activity in RET rearranged NSCLC in preclinical studies and early phase trials.

The aim of this trial is to evaluate the activity of alectinib as second-line treatment of pre-treated RET-rearranged advanced NSCLC.

Trial Scheme


Primary Endpoint: Best overall response (OR = CR or PR), per investigator assessment
Secondary Endpoints: Best overall response per independent review
Disease control at 24-weeks
Progression-free survival
Overall survival
Target Sample Size: 44 patients
Final Accrual: 14 patients
Protocol Release Date: 28 September 2017
Trial Activation Date: 18 April 2018
First Patient In: 06 November 2018
Accrual Closure Date: 03 March 2021
Global Trial Completion Date:      
03 March 2021

Trial Organisation

Trial Chairs: Enriqueta Felip and J├╝rgen Wolf
Trial Co-Chair: Egbert F. Smit
Sponsor: ETOP IBCSG Partners
Coordinating Groups: ETOP IBCSG Partners in collaboration with Lung Cancer Group Cologne
Participating Groups: Cancer Trials Ireland, SAKK and SLCG
Participating Countries: Belgium, France, Ireland, Italy, Germany, Netherlands, Portugal, Slovenia, Spain, and Switzerland

EudraCT number: 2017-002063-17

ClinicalTrials.gov: NCT03445000



Virginia Rodriguez Martinez (Clinical Trial Manager)

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ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland