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LUME-Lung 1 study design

VARGATEF® was tested in LUME-Lung 1 – a multinational, randomised, controlled phase III trial in patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy1,2

Stage IIIB/IV or recurrent NSCLC patients (all histologies)

 

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*Biomarker testing was not performed in LUME-Lung 1.

Study endpoints1,2

  • PFS
    Primary
    Progression-free survival measured by independent central review (modified RECIST criteria)
  • OS
    Key Secondary
    Overall survival (pre-specified stepwise analysis)
  • Other
    Other Secondary
    Safety, objective response disease control and health-related quality of life

LUME-Lung 1 included a pre-specified analysis and an exploratory subgroup to identify patients who benefited most1,2

NSCLC = non-small cell lung cancer;
BID = twice daily;
PO = orally;
ITT = intention to treat;
IV = intravenous;

References
  1. Reck M et al. Lancet Oncol 2014;15:143–55
  2. VARGATEF® SmPC
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