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 was to evaluate the activity of alectinib as second-line treatment of pre-treated RET-rearranged advanced NSCLC.

Trial Scheme

Trial Information

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 Jürgen Wolf
Trial Co-Chair:
Egbert F. Smit
Coordinating Groups:
ETOP in collaboration with Lung Cancer Group Cologne
Participating Groups:
Cancer Trials Ireland (CTI), Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:
Belgium, Ireland, Italy, Netherlands, Spain, Switzerland
EudraCT number: 2017-002063-17
ClinicalTrials.gov: NCT03445000


ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland