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A single arm, open label, signal-seeking, phase II trial of tepotinib in patients with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling
Australian Genomic Cancer Medicine Centre
Other Non-Commercial Sponsor
University of Sydney
This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437). This trial is evaluating tepotinib in people with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling. Participants will receive continuous tepotinib, administered orally at a dose of 500mg daily (days 1 to 21 in a21-day treatment cycle). Tepotinib is to be taken continuously with no interruption between cycles. If participants experience any severe (grade 3-4) adverse events, treatment will be withheld until the adverse event is resolved (grade 0-1). If participants experience intolerable toxicity, tepotinib dose may be reduced to 250mg once daily. Participants will receive topotinib until disease progression is documented, intolerable toxicity or withdrawal for another reason.