A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

Gastrointestinal Stromal, Neoplasms

PFS, defined as time from the date of randomization to the date of disease progression, as assessed by BICR or death due to any cause, whichever occurs first.

Confirmed ORR , as assessed by BICR; ORR is defined as the percentage of participants with a confirmed CR or PR., OS, defined as the time from the date of randomization to the date of death due to any cause., Confirmed ORR by the investigator. PFS2, by local assessment. PFS assessed by the investigator. TTR by BICR and by the investigator. DOR by BICR and by the investigator., TSST is defined as the time from the date of randomization to the earliest date of second subsequent therapy or death due to any cause., Incidence and severity of TEAEs and SAEs; dose reductions and interruptions and discontinuation of study treatment due to toxicity. Changes in vital signs, electrocardiograms, and clinical laboratory parameters., Plasma concentrations of velzatinib., Change from baseline as assessed by the EORTC QLQ-C30 Physical & Role Functioning and HRQoL domains. TTCD in Physical & Role Functioning and HRQoL, defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the Physical & Role Functioning & Global Health Status/QoL scales of the EORTC QLQ-C30, Frequency and severity of symptomatic AEs as measured by the PRO-CTCAE. Level of bother of AEs/tolerability as measured by the FACT-GP5.

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