A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer

Inclusion Criteria:

- Age ≥ 18 years

- Histologically or cytologically confirmed metastatic or advanced inoperable diagnosis
of non-small cell lung cancer (NSCLC)

- Radiographic documentation of disease progression while on previous continuous
treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
(TKI)

- All subjects must fulfill one of the following:

1. Confirmation that the tumor harbors an EGFR mutation known to be associated with
EGFR TKI sensitivity OR

2. Must have experienced clinical benefit from EGFR TKI, according to the Jackman
criteria followed by systemic objective progression while on continuous treatment
with EGFR TKI

- Dose Expansion cohort(s): subjects in the dose expansion cohorts must also have
confirmation of tumor T790M mutation status (confirmed positive) by cobas® EGFR
Mutation Test v2 from formalin-fixed paraffin-embedded tumor tissue (FFPET) or
circulating-free tumor DNA (cfDNA) plasma sample taken after disease progression on
the most recent treatment regimen (EGFR TKI or chemotherapy or other therapy).

Exclusion Criteria:

- Treatment with an EGFR TKI within 10 days or 5 half-lives of the first dose of study
treatment, whichever is longer

- Dose Expansion cohorts: Prior treatment with osimertinib (Tagrisso®). Prior treatment
with osimertinib (Tagrisso®) is allowed for subjects participating in the dose
escalation portion of the study

- Cytotoxic chemotherapy, investigational agents, or any anticancer therapy for the
treatment of advanced NSCLC (other than EGFR TKI) within 21 days of the first dose of
study treatment

- Prior treatment with immunotherapy (e.g. ipilimumab, nivolumab, pembrolizumab,
atezolizumab) within 6 months of cycle 1 day 1

- Known intermediate or strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days
prior to first dose of study treatment