Clinical Trials Archives | ALK Positive

Cancer research · NSCLC · ALK

Adjuvant alectinib significantly improves disease‑free survival versus platinum‑based chemotherapy in patients with resected ALK‑positive NSCLC (stages IB, II, and IIIA), providing a clinically meaningful benefit for CNS disease‑free survival.

Background: Platinum‑based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK‑positive non‑small‑cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib versus chemotherapy are lacking. Methods: A global, phase 3, open‑label, randomized trial enrolled patients with completely resected, ALK‑positive NSCLC (stage IB, II, or IIIA) who were randomly assigned 1:1 to oral alectinib (600 mg twice daily) for 24 months or intravenous platinum‑based chemotherapy in four 21‑day cycles. Primary endpoint: disease‑free survival (DFS), hierarchically tested among stage II/IIIA patients and then in the intent‑to‑treat population. Secondary endpoints included CNS‑DFS, overall survival, and safety. Results: 257 patients were included (130 alectinib, 127 chemotherapy). DFS at 2 years was 93.8 % in the alectinib group versus 63.0 % in chemotherapy (hazard ratio 0.24; 95 % CI 0.13‑0.45; P < 0.001) among stage II/IIIA, and 93.6 % vs 63.7 % overall (HR 0.24; 95 % CI 0.13‑0.43; P < 0.001). Alectinib improved CNS‑DFS (HR 0.22; 95 % CI 0.08‑0.58). Overall survival data were immature. No unexpected safety issues were seen. Conclusions: Adjuvant alectinib significantly improves DFS compared with platinum‑based chemotherapy in resected ALK‑positive NSCLC.

This study establishes alectinib as an effective adjuvant therapy, providing substantial DFS benefit and reduced CNS relapse that were unattained with standard chemotherapy, thereby addressing an unmet therapeutic need for resected ALK‑positive NSCLC patients.

Evidence level: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.

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