A research study to evaluate the activity of alectinib for the Treatment of pretreated patients with advanced NSCLC that have confirmed RETrearrangement.
- Conditions
- Advanced stage RET-rearranged NSCLCMedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002063-17-IT
- Lead Sponsor
- EUROPEAN THORACIC ONCOLOGY PLATFORM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
- 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 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
neoadjuvant or definitive platinum-based chemo-radiotherapy
treatments are considered as a line of treatment only if completed lesthan 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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST 1.1.;Secondary Objective: 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<br>tolerability of the treatment and to describe the<br>association of primary and secondary outcomes with tumour characteristics.;Primary end point(s): Best overall response (OR = CR or PR), per investigator assessment,<br>according to RECIST 1.1.;Timepoint(s) of evaluation of this end point: from the start of trial treatment across all time points until the end of<br>trial treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Best Overall (OR) response per independent review; disease control ; Progression-free survival (PFS); overall survival ; Safety and tolerability;Timepoint(s) of evaluation of this end point: from the start of trial treatment across all time points until the end of trial Treatment; at 24 weeks; time from the date of enrolment until documented progression or death, if progression is not documented; time from the date of enrolment until death from any cause; from the date of signature of informed consent<br>until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication