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 sites44 target enrollmentAugust 16, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 16, 2018

End Date

TBD

Last Updated

5 years ago

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