Trials / Terminated
TerminatedNCT03087708
Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine feasibility and safety of long-term administration of two doses of a peripheral opioid receptor antagonist in patients with advanced non-small cell lung cancer (NSCLC) receiving first-line systemic therapy. SECONDARY OBJECTIVES: I. To explore whether patients randomized to one or both of the two study drug arms have less decline in health-related quality of life (HRQoL) than patients randomized to placebo. II. To estimate the difference in the pain levels and opioid/non-opioid analgesic requirements between patients receiving naloxegol or placebo. III. To estimate the difference in the adverse peripheral effects of opioids (e.g. constipation, nausea/emesis, dry mouth and urinary retention) between patients receiving naloxegol or placebo. IV. To explore whether there is a signal that naloxegol may be associated with longer progression-free survival (PFS) and overall survival (OS). V. To evaluate the difference in discontinuation rate of systemic therapy due to adverse events (AEs) and deaths attributable to systemic therapy. After completion of study treatment, patients are followed up every 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naloxegol | Given PO |
| OTHER | Placebo | Given PO |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
Timeline
- Start date
- 2018-03-23
- Primary completion
- 2021-01-04
- Completion
- 2023-04-01
- First posted
- 2017-03-22
- Last updated
- 2025-07-17
- Results posted
- 2022-08-03
Locations
660 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03087708. Inclusion in this directory is not an endorsement.