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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 15, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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.