A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Summary
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Timeline
- Start
- 2018-08-16
- Primary completion
- 2023-06-26
- Completion
- 2031-11-19
Outcome
Met primary endpoint
registry analysis (superiority test); Alectinib vs Platinum-Based Chemotherapy; p = .0001; Hazard Ratio (HR) 0.24 (95% CI 0.13 to 0.45); Log Rank NCT03456076 ↗
paper Among patients with resected ALK-positive NSCLC of stage IB, II, or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy. PMID 38598794 ↗
release “The Phase III ALINA study evaluating Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis.” gene.com ↗
release “In the ALINA study, Alecensa reduced the risk of disease recurrence or death by 76%” chugai-pharm.co.jp ↗
Publications
- Barlesi F, Ahn JS, Solomon BJ, Nishio M, Dziadziuszko R, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Xu T, Bara I, Ding B, Ngiam C, Petric P, Wu YL. Disease characteristics and treatment outcomes in patients with resected early-stage ALK-positive non-small cell lung cancer from the randomized ALINA trial. Lung Cancer. 2026 Jun;216:109385. doi: 10.1016/j.lungcan.2026.109385. Epub 2026 Mar 28.
- Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Lohmann TO, Xu T, Cardona A, Hiles L, Noe J, Solomon BJ. Plain language summary of the ALINA study results: alectinib compared with chemotherapy after surgery in people with ALK-positive non-small cell lung cancer. Future Sci OA. 2025 Dec;11(1):2578145. doi: 10.1080/20565623.2025.2578145. Epub 2025 Nov 11.
- Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Ochi Lohmann T, Xu T, Cardona A, Ruf T, Noe J, Solomon BJ; ALINA Investigators. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Apr 11;390(14):1265-1276. doi: 10.1056/NEJMoa2310532.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alectinib | Small molecule | 600 mg | Oral |
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |