Clinical trial NCT02826161: 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
Official title: A Phase III Randomized, Open-Label Clinical Trial of BBI-608 Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Neoplasms
Neoplasms by Site
Lung Neoplasms
Thoracic Neoplasms
Respiratory Tract Neoplasms
Bronchial Neoplasms
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Overall Survival
timeFrame: 36 months
Secondary outcomes:
measure: Overall Survival in Biomarker Positive Patients
timeFrame: 36 months
measure: Progression Free Survival
timeFrame: 36 months
measure: Progression Free Survival in Biomarker Positive Patients
timeFrame: 36 months
measure: Disease Control Rate in Biomarker Positive Patients
timeFrame: 36 months
measure: Quality of Life (QoL)
timeFrame: 36 months
measure: Disease Control Rate
timeFrame: 36 months
measure: Number of Patients With Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Gettysburg
country: United States
state: Pennsylvania
city: Arlington
country: United States
state: Texas
Study officials:
References: