An Open-Label, Phase 2b, Global Multi-Center Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertions and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations

In this study we want to find out more about an investigational drug, zipalertinib, in people with a specific type of lung cancer. We want to find out whether the investigational drug zipalertinib (also called TAS6417 or CLN-081) may shrink or slow the growth of this kind of lung cancer, and whether it causes any problems (side effects). Everyone in this study will receive zipalertinib, which is still experimental and is not approved by the U.S. Food and Drug Administration. We are testing zipalertinib to see what effect it has on people with certain types of lung cancer with specific genetic mutations, exon 20 insertion (ex20ins), which is a gene mutation that does not respond to typical cancer treatments. We don’t know if this study will help you. Your condition may get better, but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for NSCLC in the future.