Research & Trial Information
Protocol #: A221504
Cancer Type: Non Small Cell Lung Cancer
- Advanced (stage IIIB or IV) lung adenocarcinoma diagnosed by biopsy of the primary or metastatic site.
- No known presence of known EGFR or EML4-ALK driver mutations in the tumor.
- 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.
- No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy. Prior palliative radiation permitted; prior adjuvant chemotherapy /radiation is permitted.
- No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists.
- 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.
- No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer’s disease, or uncontrolled seizures).
- 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.
- Age ≥ 18 years.
- ECOG Performance Status 0-2