A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

Summary

Objectives

This study will evaluate the safety and efficacy of zipalertinib in participants with
locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other
uncommon/single or compound Epidermal Growth Factor Receptor Proteins Mutations
(EGFRmts).

Participants will be enrolled into 1 of the 4 following cohorts:

- Cohort A ("prior ex20ins treatment") will include participants harboring EGFR
ex20ins who have progressed on or after initial treatment with standard
platinum-based chemotherapy and prior treatment with an ex20ins agent for their
advanced disease (administered together or separately).

- Cohort B ("first-line") will include participants harboring EGFR ex20ins who have
not received prior treatment for advanced or metastatic disease and are not
appropriate candidates for first-line doublet platinum-based chemotherapy or have
refused first-line doublet platinum-based chemotherapy.

- Cohort C ("active brain mets") will include participants harboring EGFR ex20ins or
other uncommon single or compound EGFRmts and active brain metastases and/or
leptomeningeal disease (LMD). Participants may or may not have had prior treatment
for advanced disease.

- Cohort D ("other uncommon EGFRmts") will include participants harboring other
non-ex20ins, excluding C797S (uncommon single or compound) EGFRmts who have not
received prior systemic therapy for their locally advanced or metastatic NSCLC
disease.