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DosingDosingDosingSafetySafetySafetyClinical TrialsClinical TrialsXALKORI Clinical TrialsROS1+ NSCLC: PROFILE 1001ALK+ NSCLC: PROFILE 1014

Real World Evidence

Real World EvidenceReal World EvidenceSequential XALKORI® and Ceritinib in ALK+ NSCLCXALKORI® and Post-Progression Treatment in ALK+ NSCLC

The information on this website is based on data from adult patients with ALK+ NSCLC treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics for Great Britain. For XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.

Clinical TrialsThe efficacy and safety of XALKORI® in adult patients with advanced NSCLC have been evaluated in the following studies:1
  • PROFILE 1014: A randomised Phase 3 trial in patients with previously untreated ALK+ advanced NSCLC (n=343)*
  • Study 1007: A randomised Phase 3 study in patients with previously treated ALK+ NSCLC (n=347)
  • Study 1001 and Study 1005: Single-arm studies in patients with ALK+ advanced NSCLC (n=149 and n=934, respectively)
  • PROFILE 1001: A single-arm study in patients with ROS1+ advanced NSCLC (n=53)*
* indicates the 2 studies that are described in further detail on this website. See below for more information regarding these. Please refer to the XALKORI® SmPC for a summary of the other studies.
PROFILE 1001 

A single-arm, open-label Phase 1 study evaluating the efficacy and safety of XALKORI® in patients with ROS1+ advanced NSCLC (n=53)1,2

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PROFILE 1014 

A randomised, open-label Phase 3 study evaluating the efficacy and safety of XALKORI® vs. chemotherapy as first-line therapy for ALK+ advanced NSCLC (n=343)1,3

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Pooled Safety Data for XALKORI®

The safety of XALKORI® has been evaluated in 1,722 patients, including patients with ALK+ advanced NSCLC (n=1,669) and ROS1+ advanced NSCLC (n=53)3

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ALK: anaplastic lymphoma kinase, NSCLC: non-small cell lung cancer, ROS: reactive oxygen species 

ReferencesXALKORI® Summary of Product Characteristics for Great Britain click here. XALKORI® Summary of Product Characteristics for Northern Ireland click here.Shaw AT, Riely GJ, Bang YJ, et al. Ann Oncol. 2019;30(7):1121-6.Solomon BJ, Mok T, Kim DW, et al. N Eng J Med. 2014;371(23):2167-77.
PP-XLK-GBR-1288. March 2024

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