FIRST AND ONLY ADJUVANT

TARGETED TREATMENT

FOR ALK+ NSCLC1,2

Alina : PHASE III, RANDOMISED, MULTICENTRE, OPEN-LABEL 
TRIAL IN PATIENTS WITH ALK+ RESECTED STAGE IB-IIIA NSCLC1,2,*

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KEY INCLUSION CRITERIA2

  • ECOG PS 0–1
  • Eligible to receive platinum-based chemotherapy
  • Adequate end-organ function
  • No prior systemic cancer therapy

ENDPOINTS2

  • Primary: DFS per investigator,‡ tested hierarchically (Stage II–IIIA → ITT [Stage IB–IIIA])
  • Secondary: OS, safety
  • Exploratory: CNS disease-free survival§

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ALECENSA IN

ALK+ RESECTED NSCLC

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*Per UICC/AJCC 7th edition.2 †Cisplatin + pemetrexed, cisplatin + vinorelbine or cisplatin + gemcitabine; cisplatin could be switched to carboplatin in case of intolerability.2 ‡DFS defined as the time from randomisation to the first documented recurrence of disease or new primary NSCLC as determined by the investigator, or death from any cause.2 §Defined as the time from randomisation to the first documented recurrence of disease in the CNS, or death from any cause.2 Pneumonectomy (ALECENSA: 2%; platinum-based chemotherapy: 3%), bilobectomy (ALECENSA: 2%; platinum-based chemotherapy: 4%), sleeve lobectomy (ALECENSA: 0%; platinum-based chemotherapy: 1%).2

 

AJCC: American Joint Committee on Cancer; ALK: anaplastic lymphoma kinase; BID: twice a day; CNS: central nervous system; DFS: disease-free survival; ECOG PS: Eastern Cooperative Oncology Group performance status; ITT: intention-to-treat; NSCLC: non-small cell lung cancer; OS: overall survival; Q3W: every 3 weeks; R: randomisation; SmPC: Summary of Product Characteristics; UICC: Union for International Cancer Control.


1. Roche. ALECENSA (alectinib) Summary of Product Characteristics. 2024. Available here (accessed July 2024); 2. Wu Y-L, et al. N Engl J Med 2024;390(14):1265–1276.