ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Jun 25, 2023
  • participants needed
    44
  • sponsor
    European Thoracic Oncology Platform
Updated on 21 April 2021
Investigator
Barbara Ruepp, PharmD
Primary Contact
The Netherlands Cancer Institute Amsterdam (0.0 mi away) Contact
+24 other location
platelet count
cancer
carcinoma
lung cancer
gilbert's syndrome
metastasis
progressive disease
neutrophil count
RET
neuropathy
cancer chemotherapy
alopecia
platinum doublet
kidney function test
lung carcinoma
alectinib

Summary

A research study to evaluate the activity of alectinib for the Treatment of pretreated patients with advanced NSCLC that have confirmed RETrearrangement.

Description

The trial is investigating the efficacy of alectinib in patients with advanced stage RET-rearranged NSCLC, treated with at least one platinum based systemic chemotherapy regimen. Preclinical studies have shown that alectinib, a highly selective next generation ALK inhibitor, has potent anti-tumour activity in RET-rearranged NSCLC. Therapeutically, several multiple kinases inhibitors, are potentially able to inhibit RET kinase function, which has been tested in several unselected NCSLC trials. However, those result were negative and none of the tested drugs was approved for lung cancer treatment.

The ALERT-lung trial is a single arm, phase II trial with the primary objective to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1 in selected NSCLC patients with RET rearrangement. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free survival (PFS), and overall survival (OS) as well as to assess safety and tolerability of the treatment and to describe the association of primary and secondary outcomes with tumour characteristics.

Alectinib is administered orally, 600 mg, twice per day, until progression, refusal or unacceptable toxicity. Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit. A total sample size of 44 patients is required.

Details
Condition Non-Small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent, Recurrent NSCLC, nsclc
Treatment Alectinib
Clinical Study IdentifierNCT03445000
SponsorEuropean Thoracic Oncology Platform
Last Modified on21 April 2021

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