A single-arm, open-label, phase II trial of entrectinib in patients with advanced tumours harbouring NTRK fusions or ROS1 gene rearrangements detected by CGP (MoST 13)
The ROS1/NTRK ASPiRATION substudy will confirm the activity of entrectinib in the treatment of ROS1 or NTRK+ metastatic NSCLC identified by comprehensive genomic profiling. Entrectinib is a tyrosine kinase inhibitor which acts on several receptors, including tropomyosin receptor tyrosine kinases (TRK) and ROS1 tyrosine-protein kinases. Entrectinib works by interfering with the growth of cancer cells, which are eventually destroyed. Entrectinib is available on the PBS for treatment of NSCLC with ROS1 gene mutation rearrangement determined by fluorescence in situ hybridisation (FISH) testing.
Summary:
A single-arm, open-label, phase II trial of entrectinib in patients with advanced tumours harbouring NTRK fusions or ROS1 gene rearrangements detected by CGP (MoST 13)
Clinical trial design:
Phase II single arm open label signal-seeking clinical trial
Indication:
Patients with advanced cancers harbouring NTRK fusions or ROS1 gene rearrangements identified using CGP. NSCLC patients with
ROS1 gene alterations must be FISH-negative, i.e. not eligible for reimbursed ROS1-targeted treatment
Intervention:
Patients will receive continuous entrectinib 600mg once daily orally until disease progression, participant withdrawal or unacceptable
toxicity.
More information:
ASPiRATION substudies include NSCLC-specific substudies and Omico MoST substudies that cater for NSCLC patients with tumours expressing the appropriate molecular biomarkers. The ASPiRATION substudies are all Phase II single arm open label signal-seeking clinical trials with the intent to demonstrate or confirm drug activity and safety in order to inform subsequent randomised Phase III clinical trials.
The ASPiRATION study and substudies are led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC), University of Sydney.
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