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

June 10, 2026 updated by: GlaxoSmithKline

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)

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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Desmond Yip
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ka Yeung Mark Wong
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Zalcberg
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Schoffski
  • Brazil
      • Porto Alegre, Brazil, 90020-090
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Lutz
      • Recife, Brazil, 50040000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Ramos Tejo Ramos Tejo Salgado
      • Vitória, Brazil, 29043-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • GLAUCIO BERTOLLO
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leticia Costa
      • São Caetano do Sul, São Paulo, Brazil, 09541-270
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Cubero
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Xiaolan Feng
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albiruni Ryan Ryan Abdul Abdul Razak
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jonathan Noujaim
        • Contact:
        • Contact:
  • China
      • Beijing, China, 100036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jian Li
        • Contact:
        • Contact:
      • Hangzhou, China, 310016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yu Zheng
      • Jinan, China, 250021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lei Cong
      • Shanghai, China, 200127
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ming Wang
        • Contact:
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kai-Xiong Tao
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201315
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ye Zhou
  • France
      • Angers, France, 49055
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • pierre kubicek
      • Bordeaux, France, 33076
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoine Italiano
      • Lille, France, 59000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Loic Lebellec
      • Lyon, France, 69373
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jean-Yves Blay
        • Contact:
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florence Duffaud
      • Saint-Herblain, France, 44805
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanuelle Bompas
      • Toulouse, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thibaud Valentin
        • Contact:
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • axel LE CESNE
  • Germany
      • Berlin, Germany
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Reichardt
      • Essen, Germany, 45122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Bauer
      • Mannheim, Germany, 68167
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bernd Kasper
        • Contact:
        • Contact:
  • Hungary
      • Pécs, Hungary, 7624
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • László Mangel
  • Italy
      • Bari, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michele Guida
      • Candiolo, Italy, 10060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Aliberti
      • Genova, Italy, 16132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Danila Comandini
      • Milan, Italy, 20133
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Rosa Fumagalli
      • Milan, Italy, 20141
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberta Giovanna Sanfilippo
      • Palermo, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giuseppe Badalamenti
      • Roma, Italy, 00128
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bruno Vincenzi
        • Contact:
        • Contact:
    • FC
      • Meldola, FC, Italy, 47014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorena Gurrieri
    • Lombardy
      • Rozzano MI, Lombardy, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexia Bertuzzi
  • Japan
      • Chiba, Japan, 277-8577
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Saori Mishima
      • Ehime, Japan, 791-0280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomohiro Nishina
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eiji Oki
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshito Komatsu
      • Kanagawa, Japan, 247-8533
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akira Sawaki
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satoshi Ida
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hisato Kawakami
        • Contact:
        • Contact:
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yukinori Kurokawa
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hidekazu Hirano
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masato Ozaka
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid M.E. Desar
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kjetil Boye
  • Poland
      • Kielce, Poland, 25-640
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Dziura
      • Poznan, Poland, 60-569
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodryg Ramlau
      • Warsaw, Poland, 02-781
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Piotr Rutkowski
  • Romania
      • Bucharest, Romania, 013823
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Iordan
      • Bucharest, Romania, 022328
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adina Emilia Croitoru
      • Craiova, Romania, 200542
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Schenker
      • Timișoara, Romania, 300166
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roxana Scheusan
  • South Korea
      • Daegu, South Korea, 41404
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byung Woog Kang
      • Seongnam-si Gyeonggi-do, South Korea, 463 707
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keun-Wook Lee
      • Seoul, South Korea, 03080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Do-youn Oh
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jungyong Hong
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min-Hee Ryu
      • Seoul, South Korea, 120-752
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Minkyu Jung
      • Suwon Kyunggi-do, South Korea, 16499
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tae Hwan Kim
      • Yangsan, South Korea, 626-770
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cheol Sik Kim
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Serrano-Garcia
      • Barcelona, Spain, 08025
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Sebio García
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nadia Hindi Muñiz
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rosa Alvarez Alvarez
        • Contact:
        • Contact:
      • Oviedo, Spain, 33006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María del Pilar Solís Hernández
      • Seville, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irene Carrasco García
      • Valencia, Spain, 46009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Augusto Aguilar Andino
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Javier Martínez Trufero
        • Contact:
        • Contact:
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruo-Han TSENG
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Li-Tzong Chen
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yen-Yang Chen
      • Taipei, Taiwan, 100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kun-Huei Yeh
      • Taipei, Taiwan, 112
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chueh-Chuan Yen
      • Taoyuan, Taiwan, 333
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chun-Nan Yeh
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Venkata Bulusu
      • Edinburgh, United Kingdom, EH4 2XR
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiangfei Yan
      • Leeds, United Kingdom, LS9 8FF
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Daniel Stark
        • Contact:
        • Contact:
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Napolitano
      • London, United Kingdom, NW12BU
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vasilios Karavasilis
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alexander Lee
        • Contact:
        • Contact:
      • Sheffield, United Kingdom, S10 2SE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robin Young
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mahesh Seetharam
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam Burgoyne
      • Los Angeles, California, United States, 90048
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Hu
      • San Francisco, California, United States, 94158
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian Schulte
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippos Costa
    • Florida
      • Jacksonville, Florida, United States, 41076
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven Attia
      • Miami, Florida, United States, 33136
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan Trent
      • Orlando, Florida, United States, 32806
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacobo Hincapie-Echeverri
      • Tampa, Florida, United States, 33612
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mauricio Ribeiro
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Rieth
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Benjamin Powers
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Suzanne George
        • Contact:
        • Contact:
      • Boston, Massachusetts, United States, 02114-2696
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Edwin Choy
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Scott Schuetze
        • Contact:
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thanh Ho
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mia Weiss
        • Contact:
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kirsten Leu
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tony Philip
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ciara Kelly
        • Contact:
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lanyi Chen
      • Rochester, New York, United States, 14642
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adrienne Victor
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Juneko Grilley-Olson
        • Contact:
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Tinoco
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Heinrich
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Margaret Von Mehren
        • Contact:
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Lefler
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Melissa Burgess
        • Contact:
        • Contact:
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ki Young Chung
        • Contact:
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Saikrishna Gadde
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Laith Abushahin
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Neeta Somaiah
        • Contact:
      • Santa Monica, Texas, United States, 90404
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Arun Singh
        • Contact:
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Stephan Kendall
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ludimila Cavalcante
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min Park
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katherine Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.
  • Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.

Exclusion Criteria:

  • GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sunitinib
Drug: Sunitinib
Sunitinib will be administered.
Experimental: IDRX-42 (GSK6042981)
Drug: IDRX-42
IDRX-42 will be administered.
Other Names:
  • velzatinib - subject to USAN approval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to approximately 130 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 261 weeks
OS is defined as time from the date of randomization to the date of death due to any cause.
Up to approximately 261 weeks
Progression-Free Survival (PFS)
Time Frame: Up to approximately 261 weeks
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 261 weeks
Time to Response (TTR)
Time Frame: Up to approximately 261 weeks
TTR is defined as time from randomization until the first documented PR or complete response (CR) that will be subsequently confirmed.
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)
Time Frame: Baseline (Day 1) and up to approximately 261 weeks
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
Baseline (Day 1) and up to approximately 261 weeks
Time To Confirmed Deterioration (TTCD)
Time Frame: Up to approximately 261 weeks
TTCD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration based on the EORTC QLQ-C30.
Up to approximately 261 weeks
Plasma concentrations of IDRX-42 (GSK6042981)
Time Frame: Up to approximately 261 weeks
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
Up to approximately 261 weeks
Number of Participants with TEAEs and SAEs by severity
Time Frame: Up to approximately 261 weeks
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
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)
Time Frame: Up to approximately 261 weeks
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.
Up to approximately 261 weeks
Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)
Time Frame: Up to approximately 261 weeks
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.
Up to approximately 261 weeks
Confirmed Overall Objective Response Rate (ORR)
Time Frame: Up to approximately 261 weeks
ORR is defined as the percentage of participants with the best overall confirmed partial response (PR) or complete response (CR).
Up to approximately 261 weeks
Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)
Time Frame: Up to approximately 261 weeks
PFS2 is defined as the time from initial study randomization to the disease progression following first subsequent anticancer therapy or death, whichever is first.
Up to approximately 261 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

November 29, 2030

Study Registration Dates

First Submitted

October 17, 2025

First Submitted That Met QC Criteria

October 17, 2025

First Posted (Actual)

October 21, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300383
  • 2025-522229-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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