A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Overall Survival (OS)

OS is defined as time from the date of randomization to the date of death due to any cause.

Time frame: Up to approximately 261 weeks

Progression-Free Survival (PFS)

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

Time frame: Up to approximately 261 weeks

Confirmed Overall Objective Response Rate (ORR)

ORR is defined as the percentage of participants with the best overall confirmed partial response (PR) or complete response (CR).

Time frame: Up to approximately 261 weeks

Time to Response (TTR)

TTR is defined as time from randomization until the first documented PR or complete response (CR) that will be subsequently confirmed.

Time frame: Up to approximately 261 weeks

Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)

PFS2 is defined as the time from initial study randomization to the disease progression following first subsequent anticancer therapy or death, whichever is first.

Time frame: Up to approximately 261 weeks

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)

The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. These include functional scales, symptom scales, global health status scale, and single item scales. Scores are averaged and transformed to 0 to 100. Higher scores indicate greater functioning, better global health status, or more severe symptoms

Time frame: Baseline (Day 1) and up to approximately 261 weeks

Time To Confirmed Deterioration (TTCD)

TTCD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration based on the EORTC QLQ-C30.

Time frame: Up to approximately 261 weeks

Plasma concentrations of IDRX-42 (GSK6042981)

Time frame: Up to approximately 261 weeks

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Up to approximately 261 weeks

Number of Participants with TEAEs and SAEs by severity

Time frame: Up to approximately 261 weeks

Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity

Time frame: Up to approximately 261 weeks

Number of participants with symptomatic adverse events (AEs), by severity, as measured by the Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.

Time frame: Up to approximately 261 weeks

Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)

The FACT GP5 is an assessment focused on the overall side effects impact to inform the tolerability of a treatment. The FACT GP5 ("I am bothered by side effects of treatment") responses are given on a 5-point Likert type scale. The response scale ranges from 0 (Not at all) to 4 (Very much). Higher scores indicate a higher degree of AE bother.

Time frame: Up to approximately 261 weeks