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Clinical Trial 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.


Clinical Trial 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 pemetrexed-based chemotherapy.

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 chemotherapy due to adverse events (AEs) and deaths attributable to chemotherapy.

After completion of study treatment, patients are followed up every 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03087708
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact Pankaj Gupta, MD
Phone 612-467-4135
Email pankaj.gupta@va.gov
Status Recruiting
Phase Phase 2
Start date October 13, 2017
Completion date October 2020

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