Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedNaloxegol and Placebo

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 17, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?660 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

Study overview

What this study is about

Purpose: Supportive Care
Study type: Interventional
Phase: Phase 2
Sponsor: Alliance for Clinical Trials in Oncology
Interventions being studied: Drug: Naloxegol; Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the primary or metastatic site (American Joint Committee on Cancer 7.0)
No known presence of known EGFR or EML4-ALK driver mutations in the tumor
Started first-line systemic therapy of the investigator's choice within 12 weeks prior to registration, or planning to initiate first-line systemic therapy of the investigator's choice within 4 weeks after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiation
No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy (other than current treatment); prior palliative radiation permitted; prior adjuvant systemic therapy /radiation is permitted
No more than 7 days of prior use of mixed opioid agonist/opioid antagonists or other opioid antagonists within 4 weeks before registration; patients should not receive such medications after registration and for the entire duration of study treatment
No methadone within 4 weeks prior to registration
Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration; current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required
Expected survival \> 3 months
No concurrently active second invasive malignancies except non-melanoma skin cancer
No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall; no abdominal surgery within 60 days of registration
No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)
No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)
No symptomatic and untreated brain metastases; patients will be eligible for study if radiation therapy for brain metastases was completed at least 7 days prior to registration
Patients having received stereotactic radiation will be eligible if the radiation was completed at least 7 days prior to registration
Patients having undergone surgical resection of brain metastases will be eligible after they have healed and recovered from the surgical intervention sufficiently to start systemic treatment for NSCLC, as determined by a neurosurgeon
No known leptomeningeal carcinomatosis
No history of myocardial infarction =\< 6 months prior to registration; no current symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac arrhythmias
No severe hepatic impairment (Child-Pugh class C) or acute liver disease
No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients
No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) \>= 1,500/mm\^3
Platelet count \>= 100,000/mm\^3
Calculated (calc.) creatinine clearance \>= 60 mL/min calculated using the Cockcroft-Gault formula
Total bilirubin =\< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Anchorage Associates in Radiation MedicineAnchorage, Alaska
Anchorage Radiation Therapy CenterAnchorage, Alaska
Alaska Breast Care and Surgery LLCAnchorage, Alaska
Alaska Oncology and Hematology LLCAnchorage, Alaska
Alaska Women's Cancer CareAnchorage, Alaska
Anchorage Oncology CentreAnchorage, Alaska
Katmai Oncology GroupAnchorage, Alaska
Providence Alaska Medical CenterAnchorage, Alaska
Fairbanks Memorial HospitalFairbanks, Alaska
Kingman Regional Medical CenterKingman, Arizona
CHI Saint Vincent Cancer Center Hot SpringsHot Springs, Arkansas
Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 17, 2025. Always confirm current availability with the study team.

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