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
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.
Checked against the public recordLast updated Nov 15, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Sumitomo Pharma America, Inc.
- Interventions being studied
- Drug: Napabucasin; Drug: Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationBeverly Hills, California
- Study locationSanta Rosa, California
- Study locationAventura, Florida
- Study locationGettysburg, Pennsylvania
- Study locationArlington, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 15, 2023. Always confirm current availability with the study team.