Osimertinib is used to treat a type of lung cancer that has specific changes (mutations) in a gene called EGFR. Although tumors will usually shrink (respond) during treatment with osimertinib, they can stop responding, or become resistant, to osimertinib. A common cause of resistance is ‘MET amplification’, which describes when extra copies of a gene called MET are present. Lung cancer that is resistant to osimertinib due to MET amplification could be treated by combining osimertinib with a treatment that blocks MET, such as tepotinib. INSIGHT 2 is an ongoing study that is designed to learn about the effects and safety of tepotinib combined with osimertinib, in patients with lung cancer that has stopped responding to osimertinib because of MET amplification.
Here, we describe the rationale and design of the INSIGHT 2 trial (NCT03940703; EudraCT 2019-001538-33), a global, two-arm, open-label, phase II trial assessing the efficacy, safety and tolerability of tepotinib plus osimertinib in patients with advanced/metastatic non-small-cell lung cancer (NSCLC) harboring activating EGFR mutations, who have progressed on first-line osimertinib and have MET amplification (METamp). Read more.