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

ALERT 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
Protocol Release: 2 March 2018

Trial Organisation

Trial Chairs: Enriqueta Felip and Jürgen Wolf
Trial Co-Chair: Egbert F. Smit
Sponsor: ETOP
Coordinating Groups: ETOP 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
 Registrations:

EudraCT number: 2017-002063-17

ClinicalTrials.gov: NCT03445000

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