A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer

Key Inclusion Criteria:

- Must have histologically or cytologically confirmed non-squamous NSCLC.

- Must have progressed following treatment with platinum-based combination chemotherapy
for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must
have received appropriately targeted treatment.

- Must have received either nivolumab or pembrolizumab or a different IND-approved
anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated

- Weekly paclitaxel must be an acceptable treatment option

- Must submit tumor tissue for correlative analyses

- Women of child-bearing potential and partners of women of child-bearing potential must
take measures to avoid pregnancy while receiving and for a period of time following
protocol therapy

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
adequate organ function, and a life expectancy of ≥ 3 months

Key Exclusion Criteria:

- Has squamous NSCLC

- Has received prior systemic treatment with a taxane for advanced/metastatic disease

- Has received systemic anti-cancer therapy within the 14 days prior to randomization

- Has received radiotherapy within the 28 days prior to randomization, with the
exception of palliative radiotherapy to focal lesions for pain or other symptom
control

- Has brain metastases with evolving neurologic symptoms or a steroid requirement.

- Has had major surgery requiring general anesthesia and/or mechanical ventilation
within the 28 days prior to randomization

- Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a
new abnormal finding that is clinically significant

- Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)

- Refuses to complete quality of life questionnaires either alone or with assistance
from study staff despite adequate fluency

- Has an intercurrent (non-malignant) chronic medical or psychiatric illness or
condition(s) not optimally controlled and carrying a moderate to high risk of
interfering with protocol therapy administration or compliance with required
procedures, in the judgment of the investigator