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

• Status: Terminated
• Trial end date: 2017-04-24
• Target enrollment: 0
• Participant gender: All

Summary

This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Biomedical, Inc; Sumitomo Dainippon Pharma Oncology, Inc
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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