First-Line Treatment of Advanced or Metastatic NSCLC with ALK Gene Fusion
This protocol applies to patients with advanced or metastatic non-small cell lung cancer (NSCLC) in whom molecular testing has identified an ALK gene fusion — a genomic finding that defines a distinct biological subtype and directly guides first-line treatment selection.
ALK gene fusions occur in approximately 5% of NSCLC patients. The presence of this fusion is associated with responsiveness to oral ALK-targeted kinase inhibitors, making it a critical biomarker to identify before initiating systemic therapy.
First-line management is built around oral targeted therapy directed at ALK. Multiple ALK inhibitors are supported by evidence, with certain agents designated as preferred options and others recommended for use in specific clinical circumstances. The complete evidence-based regimen — including agent selection, preferred options, and clinical guidance — is available in the full protocol.
References
- An ALK gene fusion is present in about 5% of patients with NSCLC.
- The presence of an ALK gene fusion is associated with responsiveness to oral ALK TKIs.
- The Panel recommends alectinib, brigatinib, ensartinib, or lorlatinib as preferred first-line therapy options for patients with advanced or metastatic NSCLC and ALK gene fusion.
- Ceritinib and crizotinib are recommended as treatment options that may be useful in certain circumstances.