A Phase 2 Study of Zipalertinib in People With Advanced Non-Small Cell Lung Cancer


Full Title

An Open-Label, Phase 2b, Global Multicenter 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 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations


The purpose of this study is to see how well zipalertinib works to treat advanced lung cancer. The people in this study have non-small cell lung cancer (NSCLC) that has spread. The cancer also has a mutation (change) in the EGFR gene. When people have an EGFR mutation, the EGFR protein on their cells can trigger cancer growth.

Zipalertinib works against the EGFR protein to slow or stop the growth of NSCLC. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have NSCLC that has spread and has an EGFR mutation.
  • Have completed prior radiation therapy, immunotherapy, or major surgery at least 4 weeks before getting zipalertinib.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please call Dr. Helena Yu’s office at 646-608-3912.




Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID