EUCTR2017-002063-17-IT
Active, not recruiting
Phase 1
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 pre-treated RET-rearranged advanced non-small cell lung c
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EUROPEAN THORACIC ONCOLOGY PLATFORM
- Enrollment
- 44
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically or cytologically\-documented non\-small cell lung
- •\- 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
- •\- RET rearrangement detected by FISH, Nanostring or by parallelsequencing
- •on FFPE tumour tissue (biopsy, resection or cytoblock)
- •assessed locally.
- •\- Availability of FFPE tumour material for central confirmation of RETrearrangement
- •\- At least one prior platinum\-based systemic regimen: Adjuvant or
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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