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