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

ETOP (European Thoracic Oncology Platform)0 sites14 target enrollmentJanuary 12, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 12, 2018

End Date

October 12, 2021

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ETOP (European Thoracic Oncology Platform)

•\- Histologically or cytologically\-documented non\-small cell lung carcinoma
•\- Advanced disease defined as recurrent stage IV (according to 8th TNM classification) or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical
•resection, or definitive chemo\-radiation therapy for locally advanced disease)
•\- RET rearrangement detected by FISH, Nanostring or by parallel\-sequencing on FFPE tumour tissue (biopsy, resection or cytoblock) assessed locally.
•\- Availability of FFPE tumour material for central confirmation of RET\-rearrangement
•\- At least one prior platinum\-based systemic regimen: Adjuvant or neoadjuvant or definitive platinum\-based chemo\-radiotherapy treatments are considered as a line of treatment only if completed less than 6 months before enrolment. Maintenance therapy following platinum doublet\-based chemotherapy is not considered a separate regimen of therapy.
•\- Measurable or non\-measurable, but radiologically evaluable (except for skin lesions) disease according to RECIST v1\.1 criteria
•\- Adequate haematological, renal and liver function
•\- ECOG Performance Status 0\-2
•Are the trial subjects under 18? no

•\- Untreated, active CNS metastases
•\- Carcinomatous meningitis
•\- Baseline symptomatic bradycardia
•\- Prior treatment with any RET TKI or RET targeted therapy
•\- Known EGFR, ALK, ROS, and BRAF mutation (in addition to RET rearrangement)
•\- Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post\-major bowel resection
•\- History of hypersensitivity to any of the additives in the alectinib drug formulation
•\- Pregnant or lactating women
•\- Known HIV positivity or AIDS\-related illness
•\- Any concurrent systemic anticancer therapy