Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
Conditions
Brief summary
Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed. This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.
Interventions
DRUGPaclitaxel
Sponsors
National Cancer Institute (NCI)
Mercator MedSystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Life expectancy of at least 12 weeks * Adequate bone marrow, liver, and renal function * Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care * Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer * Measurable disease with obstruction into the airway * Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer * Patients undergo recanalization procedure of tumor during bronchoscopy * Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization
Exclusion criteria
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer * Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study * Uncontrolled infection * Presence or recent history of any systemic disorder or conditions, such as: * uncontrolled hypertension * type 1 diabetes * severe pulmonary hypertension * acute kidney injury * stroke (within the last 6 month) * myocardial infarction (within the last 3 months) * Individuals with neurological, mental or psychiatric disorders * Concurrent participation in another study involving investigational drugs or investigational medical devices * Other (non-cancer) disease not stabilized within 1 month before the Screening Visit * Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media * Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment safety | 12 weeks | Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs) |
| Technical success | procedure day | Device deployment and infusion success |
Secondary
| Measure | Time frame |
|---|---|
| Airway patency improvements | 6 weeks |
| Quality of Life | 12 weeks |
Countries
United States
Outcome results
None listed