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Mu-opioid Receptor Antagonist

Laboratory Biomarker Analysis for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expected survival > 3 months
No methadone within 4 weeks prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of naloxegol for treating patients with stage IIIB-IV non-small cell lung cancer.

Eligible Conditions
  • Stage IV Non-small Cell Lung Cancer
  • Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are expected to live for at least three more months.
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You cannot have taken methadone for 4 weeks before enrolling in the study.
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You have used opioid medication for pain during the 4 weeks before joining the study. You can continue to use opioids during the study if needed, but it is not mandatory.
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You don't have any medical conditions that could affect the ability of drugs to reach your brain (such as multiple sclerosis, recent brain injury, Alzheimer's disease, or uncontrolled seizures).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Observed Accrual Rate Defined as Rate of Accrual Remaining >= 80% of the Expected
Proportion of Patients Alive Who Continue Study Drug and Complete the Health-related Quality of Life and Other Forms
Secondary outcome measures
Analgesic Use
Change in Function Subscales
Change in Lung Cancer Subscale of the Functional Assessment of Cancer Therapy-Lung
+9 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Group I (lower dose naloxegol, placebo)Active Control4 Interventions
Patients receive lower dose naloxegol PO QD and placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Group II: Group II (placebo, higher dose naloxegol)Active Control4 Interventions
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Group III: Group III (placebo)Placebo Group3 Interventions
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,596 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,584 Total Patients Enrolled
Pankaj Gupta, MDStudy ChairMinneapolis VA Health Care System (University of Minnesota)
1 Previous Clinical Trials
155 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the anticipated outcomes of this research endeavor?

"This clinical trial seeks to assess the proportion of patients that are alive and continue taking study drug for up to two years, as well as measuring opioid-induced constipation rating scales, unexpected side effects from chemotherapy treatments, and overall survival. Statistical analysis such as Wilcoxon tests, Fisher's exact test, and a Cox proportional hazards model will be used to compare treatment arms vs placebo arm in order to gain further insights into these objectives."

Answered by AI

Has this remedy already been studied in other investigations?

"Currently, 3 clinical trials are running to test the efficacy of this treatment. One of these is in its third phase and 666 sites across the nation have been enlisted to run studies on it; notably, many are based out of Columbia, Missouri."

Answered by AI

How widespread is the implementation of this trial?

"This trial has 100 open slots across various medical centres like Munson Medical Center in Traverse City, Mitchell Folbe MD PC in Sterling Heights, and Hematology Oncology Consultants-Clarkston in Clarkston. Additionally, there are a number of other sites that also participate."

Answered by AI

Are there slots available for participation in this trial?

"Per the clinicaltrials.gov database, this particular study is not accepting any further applicants at this moment in time; it was initially posted on October 13th 2017 and last updated July 11th 2022. Though this trial has closed recruitment, there are 1913 other studies presently recruiting participants."

Answered by AI

How many participants are being accepted into this research endeavor?

"This trial is not currently enrolling participants, although it was initially published on October 13th 2017 and last updated July 11th 2022. If you are searching for other studies, there are presently 1910 clinical trials actively recruiting patients with lung cancer as well as 3 active research projects relevant to this medication."

Answered by AI

Has this therapeutic option been bestowed regulatory approval by the FDA?

"Our team has given this treatment a safety score of 2, as it is in its Phase 2 trial and there are some indications that the intervention may be safe but insufficient evidence to support efficacy."

Answered by AI
~7 spots leftby Mar 2025