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Bending the Curve Trial by Trial
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ALINA

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Phase 3N = 257NCT03456076

Population
Completely resected ALK-positive NSCLC of stage IB (tumours 4 cm or larger), II or IIIA (AJCC/UICC seventh edition)
Design
Global, open-label, randomised phase 3 trial (1:1). Alectinib 600 mg orally twice daily for 24 months versus intravenous platinum-based chemotherapy in four 21-day cycles. Primary endpoint disease-free survival, tested hierarchically in stage II or IIIA disease and then in the intention-to-treat population.
Primary endpoint
DFS
Arms
  • Platinum-based chemotherapy (control, n = 127): Intravenous platinum-based chemotherapy, four 21-day cycles
  • Alectinib (experimental, n = 130): Alectinib 600 mg orally twice daily for 24 months
People
Wu YL
DFSHR 0.24 (95% CI 0.13–0.45)Δ 24-month DFS+30.8 pointsDFSHR 0.24 (95% CI 0.13–0.43)Δ 24-month DFS+29.9 points
Show the numbers
Results reported for ALINA
EndpointAnalysisAlectinibPlatinum-based chemotherapyEffect
DFSPatients with stage II or IIIA diseasePercentage alive and disease-free at 2 years; hazard ratio for disease recurrence or deathprimaryWu 202493.8% at 2 y63% at 2 yHR 0.24 (95% CI 0.13–0.45)P<0.001The abstract gives 2-year percentages and a hazard ratio; it does not give median DFS.
DFSPercentage alive and disease-free at 2 years; hazard ratio for disease recurrence or deathprimaryWu 202493.6% at 2 y63.7% at 2 yHR 0.24 (95% CI 0.13–0.43)P<0.001Secondary endpoint, CNS disease-free survival: hazard ratio for CNS disease recurrence or death 0.22 (95% CI 0.08 to 0.58); the abstract does not state the population or event counts for that analysis. Overall survival data were immature.
Results reported for ALINA
EndpointAnalysisAlectinibPlatinum-based chemotherapyEffect
DFSPatients with stage II or IIIA diseasePercentage alive and disease-free at 2 years; hazard ratio for disease recurrence or deathprimaryWu 202493.8% at 2 y63% at 2 yHR 0.24 (95% CI 0.13–0.45)P<0.001The abstract gives 2-year percentages and a hazard ratio; it does not give median DFS.
DFSPercentage alive and disease-free at 2 years; hazard ratio for disease recurrence or deathprimaryWu 202493.6% at 2 y63.7% at 2 yHR 0.24 (95% CI 0.13–0.43)P<0.001Secondary endpoint, CNS disease-free survival: hazard ratio for CNS disease recurrence or death 0.22 (95% CI 0.08 to 0.58); the abstract does not state the population or event counts for that analysis. Overall survival data were immature.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.240.13–0.45
DFS0.240.13–0.43
Primary publication: Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, et al. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024;390(14):1265-1276. PubMedDOI

Appears in

Sources

  1. Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, et al. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024;390(14):1265-1276.

    PubMedDOI