LORLATINIB TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Concurrent use of strong CYP3A inducers
- History of interstitial fibrosis or interstitial lung disease
- Severe renal impairment (i.e. CrCl < 15 ml/min using Cockroft-Gault or ESRD requiring dialysis)
- Baseline moderate to severe hepatic impairment [i.e. total bilirubin ≥ 1.5 x ULN with any AST OR AST/ALT > 2.5 x ULN (>5 x ULN in patients with liver metastases)]
- Inadequate bone marrow function (i.e. ANC < 1,500/mm3, PLT < 100,000/mm3, Hgb < 9 g/dL)
- Pregnancy (i.e. known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care provided by a VA/VA Community Care oncology provider
- Goals of care and role of Palliative Care consult discussed and documented
- ECOG Performance Status 0-2
Additional Inclusion Criteria (Clinical Indications)
- Metastatic non-small cell lung cancer (NSCLC) with a confirmed ALK mutation AND progressive disease or intolerance to at least one prior ALK TKI (e.g. crizotinib, alectinib, brigatinib, ceritinib)
- Metastatic NSCLC with a confirmed ROS1 rearrangement AND progressive disease or intolerance to entrectinib or crizotinib