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Clinical Data

Larotrectinib efficacy and safety have been evaluated in three clinical trials in patients with cancers with NTRK gene fusion [1-3]. Patients were to have unresectable or metastatic solid tumours progressing following systemic therapy or requiring surgery with substantial morbidity for locally-advanced disease [1, 2].

Patients were prospectively identified as carrying the NTRK gene fusion, detected by molecular profiling as routinely performed at each site, and consecutively enrolled into one of three open-label, single-arm protocols [1, 2]:

  • A phase 1 study in adults (LOXO-TRK-14001; NCT02122913) [4];
  • A phase 1/2 study in children (SCOUT; NCT02637687); and
  • A phase 2 “basket” study in adolescents and adults (NAVIGATE; NCT02576431).

Click on the following links to learn more about the currently available efficacy and safety outcomes from these trials.