A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC
- Conditions
- RET-rearranged advanced non-small cell lung cancer1003866610029107
- Registration Number
- NL-OMON46669
- Lead Sponsor
- European Thoracic Oncology Platform (ETOP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is the best overall response (OR = complete<br /><br>response or partial response), per investigator assessment, according to RECIST<br /><br>1.1., from the start of trial treatment across all time points until the end of<br /><br>trial treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Best overall response per independent review<br /><br>- Disease control at 24-weeks: best overall response of complete response or<br /><br>partial response, or stable disease (or non-complete response/non-progressive<br /><br>disease in the case of non-measurable disease only)<br /><br>- Progression-free survival defined as the time from the date of enrolment<br /><br>until documented progression or death, if progression is not documented<br /><br>- Overall survival defined as time from the date of enrolment until death from<br /><br>any cause<br /><br>- Safety and tolerability</p><br>