Adjuvant targeted therapy (for patients with ALK variants)

The global, phase III, open-label ALINA trial (NCT03456076) included 257 patients with completely resected stage IB (tumors ≥4 cm), II, or IIIA (AJCC 7th edition staging criteria) NSCLC and an ALK variant. Patients were randomly assigned in a 1:1 ratio to receive either oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was DFS, tested hierarchically among patients with stage II or IIIA disease and then in the ITT population. Secondary end points included central nervous system (CNS) DFS, OS, and safety.[26]

The global, phase III, open-label ALINA trial (NCT03456076) included 257 patients with completely resected stage IB (tumors ≥4 cm), II, or IIIA (AJCC 7th edition staging criteria) NSCLC and an ALK variant. Patients were randomly assigned in a 1:1 ratio to receive either oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was DFS, tested hierarchically among patients with stage II or IIIA disease and then in the ITT population. Secondary end points included central nervous system (CNS) DFS, OS, and safety.[26]

The median duration of follow-up for survival was 27.8 months (27.8 months in the alectinib group and 28.4 months in the chemotherapy group).

The global, phase III, open-label ALINA trial (NCT03456076) included 257 patients with completely resected stage IB (tumors ≥4 cm), II, or IIIA (AJCC 7th edition staging criteria) NSCLC and an ALK variant. Patients were randomly assigned in a 1:1 ratio to receive either oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was DFS, tested hierarchically among patients with stage II or IIIA disease and then in the ITT population. Secondary end points included central nervous system (CNS) DFS, OS, and safety.[26]

The 2-year DFS rate was 93.8% in the alectinib group and 63.0% in the chemotherapy group (stage II/IIIA) (HRdisease recurrence or death, 0.24; 95% CI, 0.13–0.45; P < .001).[26][Level of evidence B1]

The global, phase III, open-label ALINA trial (NCT03456076) included 257 patients with completely resected stage IB (tumors ≥4 cm), II, or IIIA (AJCC 7th edition staging criteria) NSCLC and an ALK variant. Patients were randomly assigned in a 1:1 ratio to receive either oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was DFS, tested hierarchically among patients with stage II or IIIA disease and then in the ITT population. Secondary end points included central nervous system (CNS) DFS, OS, and safety.[26]

The ITT population included patients with stage IB, II, or IIIA disease who had been randomly assigned. The DFS rate in the ITT population was 93.6% for patients who received alectinib and 63.7% for patients who received chemotherapy (HR, 0.24; 95% CI, 0.13–0.43; P < .001).

The global, phase III, open-label ALINA trial (NCT03456076) included 257 patients with completely resected stage IB (tumors ≥4 cm), II, or IIIA (AJCC 7th edition staging criteria) NSCLC and an ALK variant. Patients were randomly assigned in a 1:1 ratio to receive either oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was DFS, tested hierarchically among patients with stage II or IIIA disease and then in the ITT population. Secondary end points included central nervous system (CNS) DFS, OS, and safety.[26]

The HRCNS disease recurrence or death was 0.22 (95% CI, 0.08–0.58) in favor of alectinib.

The global, phase III, open-label ALINA trial (NCT03456076) included 257 patients with completely resected stage IB (tumors ≥4 cm), II, or IIIA (AJCC 7th edition staging criteria) NSCLC and an ALK variant. Patients were randomly assigned in a 1:1 ratio to receive either oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was DFS, tested hierarchically among patients with stage II or IIIA disease and then in the ITT population. Secondary end points included central nervous system (CNS) DFS, OS, and safety.[26]

OS data are immature.