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Integrity plus alina6/1/2023 ![]() The primary endpoint is disease-free survival per investigator secondary endpoints are overall survival, safety, and pharmacokinetics. Treatment will continue until planned completion, disease recurrence, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Data enrichment offers a more contextualized perspective of existing data sets which supports better decision-making and maximizes the value of an organization’s data assets. It requires context or connections with other data points to provide value. Stratification factors are disease stage (stage IB vs stage II vs stage IIIA) and race (Asian vs non-Asian). Data integrity is about more than high-quality data. Patients (N=255) from ~170 centers across ~30 countries will be randomized 1:1 to receive twice-daily alectinib 600mg for 24 months or four 21-day cycles of platinum-based chemotherapy (cisplatin 75mg/m 2 plus vinorelbine 25mg/m 2 or gemcitabine 1250mg/m 2 or pemetrexed 500mg/m 2 ) according to local prescribing information. Adult patients (≥18 years) with completely resected stage IB (tumors ≥4cm) to IIIA disease and ECOG PS 0–1 are eligible for inclusion. Methods: ALINA is a randomized, multicenter, open-label phase III study investigating the efficacy and safety of adjuvant alectinib versus chemotherapy in ALK+ NSCLC (confirmed by an FDA-approved and CE-marked test). The ongoing ALINA trial will compare alectinib versus chemotherapy as adjuvant treatment for patients with stage IB–IIIA ALK+ NSCLC. Alectinib, a potent ALK inhibitor, is the SoC first-line treatment for advanced ALK+ NSCLC. Registered Office: Integrity Plus Ltd,9a Mill Lane, Donington, Spalding, Lincolnshire, PE11 4TL T: 01775 821784 Fax: 01775 822375 E. ![]() Treatment of advanced ALK+ NSCLC with ALK inhibitors improves efficacy and safety compared with chemotherapy. Approximately 5% of patients with NSCLC harbor an oncogenic fusion of the ALK gene. Adjuvant chemotherapy produces a 4–5% increase in 5-year survival rates, leaving significant unmet need for improved treatments. Although patients with stage IA NSCLC do not benefit from adjuvant chemotherapy, patients with stage IB disease and large tumors (≥4cm) do. Platinum-based adjuvant chemotherapy is the standard of care (SoC) for stage II–IIIA disease. Background: Patients with early-stage NSCLC (stage IA–IIIA) account for ~40% of cases at diagnosis despite surgery, 5-year survival rates are low.
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