Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations Clinical Trial
Official 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 evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations.
This study will evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or compound EGFRmt. Patients will be enrolled into 1 of the 4 following cohorts: - Cohort A ("prior ex20ins treatment") will include patients harboring EGFR ex20ins mutations who have progressed on or after initial treatment with standard platinum-based chemotherapy and prior treatment with an ex20 agent for their advanced disease (administered together or separately). - Cohort B ("1st line") will include patients harboring EGFR ex20ins mutations who have not received prior treatment for advanced disease. - Cohort C ("active brain mets") will include patients harboring EGFR ex20ins or other uncommon single and compound mutations and active brain metastases. Patients may or may not have had prior treatment for advanced disease. - Cohort D ("other uncommon EGFRmt") will include patients harboring other, non ex20ins uncommon single or compound EGFRmt who have progressed on or after treatment with standard systemic anticancer therapy. ;