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A Randomized, Double-Blind, Placebo Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma).

Research & Trial Information

SCHEMA A221504

Protocol #: A221504

Cancer Type: Non Small Cell Lung Cancer

Eligibility Criteria:

  1. Advanced (stage IIIB or IV) lung adenocarcinoma diagnosed by biopsy of the primary or metastatic site.
  2. No known presence of known EGFR or EML4-ALK driver mutations in the tumor.
  3. Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration. No planned initiation of definitive (potentially curative) concurrent chemo-radiation.
  4. No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy. Prior palliative radiation permitted; prior adjuvant chemotherapy /radiation is permitted.
  5. No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists.
  6. No methadone within 4 weeks prior to registration.
  7. 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.
  8. Expected survival > 3 months.
  9. No concurrently active second invasive malignancies except non-melanoma skin cancer.
  10. 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.
  11. No acute gastrointestinal conditions.
  12. No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer’s disease, or uncontrolled seizures).
  13. No history of myocardial infarction ≤ 6 months prior to registration. No current symptomatic congestive heart failure, uncontrolled angina or uncontrolled cardiac arrhythmias.
  14. No severe hepatic impairment (Child-Pugh class C) or acute liver disease.
  15. No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients.
  16. No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers.
  17. Age ≥ 18 years.
  18. ECOG Performance Status 0-2

 

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