A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)
2 other identifiers
interventional
450
5 countries
20
Brief Summary
The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2025
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2025
CompletedFirst Posted
Study publicly available on registry
October 21, 2025
CompletedStudy Start
First participant enrolled
December 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 29, 2030
January 30, 2026
January 1, 2026
2.5 years
October 17, 2025
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to approximately 130 weeks
Secondary Outcomes (13)
Overall Survival (OS)
Up to approximately 261 weeks
Progression-Free Survival (PFS)
Up to approximately 261 weeks
Confirmed Overall Objective Response Rate (ORR)
Up to approximately 261 weeks
Time to Response (TTR)
Up to approximately 261 weeks
Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)
Up to approximately 261 weeks
- +8 more secondary outcomes
Study Arms (2)
IDRX-42 (GSK6042981)
EXPERIMENTALSunitinib
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
- Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
- Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.
You may not qualify if:
- Known untreated or active central nervous system metastases.
- Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (20)
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Chiba, 277-8577, Japan
GSK Investigational Site
Ehime, 791-0280, Japan
GSK Investigational Site
Fukuoka, 812-8582, Japan
GSK Investigational Site
Hokkaido, 060-8648, Japan
GSK Investigational Site
Kanagawa, 247-8533, Japan
GSK Investigational Site
Osaka, 565-0871, Japan
GSK Investigational Site
Tokyo, 104-0045, Japan
GSK Investigational Site
Changhua, 500, Taiwan
GSK Investigational Site
Kaohsiung City, 807, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
London, SW3 6JJ, United Kingdom
GSK Investigational Site
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2025
First Posted
October 21, 2025
Study Start
December 3, 2025
Primary Completion (Estimated)
May 30, 2028
Study Completion (Estimated)
November 29, 2030
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.