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NCT07218926 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Gastrointestinal Neoplasms, sponsored by GlaxoSmithKline.

Recruiting
Registry status
Phase 3
Development phase
450
Enrollment target
20
Study locations

NCT07218926: Recruiting Phase 3 study of Gastrointestinal Neoplasms, sponsored by GlaxoSmithKline.

NCT07218926 is a Phase 3 study of Gastrointestinal Neoplasms that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 450 participants, below the 929-participant average among 12 other Gastrointestinal Neoplasms trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07218926, a Phase 3 study of Gastrointestinal Neoplasms, is actively recruiting participants, sponsored by GlaxoSmithKline.

RECRUITING
Registry status
Phase 3
Development phase
450 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

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.

Conditions Studied

Gastrointestinal Neoplasms

Interventions

  • DRUG Sunitinib
  • DRUG IDRX-42

Study Locations (20)

Other

  • GSK Investigational Site - Chiba
  • GSK Investigational Site - Ehime
  • GSK Investigational Site - Fukuoka
  • GSK Investigational Site - Hokkaido
  • GSK Investigational Site - Kanagawa
  • GSK Investigational Site - Osaka
  • GSK Investigational Site - Tokyo
  • GSK Investigational Site - Changhua
  • GSK Investigational Site - Kaohsiung City
  • GSK Investigational Site - Taipei
  • GSK Investigational Site - London
  • GSK Investigational Site - Manchester

Massachusetts

  • GSK Investigational Site - Boston

Nebraska

  • GSK Investigational Site - Omaha

New York

  • GSK Investigational Site - New York

Pennsylvania

  • GSK Investigational Site - Philadelphia

Tennessee

  • GSK Investigational Site - Knoxville

Texas

  • GSK Investigational Site - Houston

Washington

  • GSK Investigational Site - Tacoma

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2025-12-03
Est. Completion 2030-11-29
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What NCT07218926 shows while recruiting

NCT07218926 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 929-participant average among 12 other Gastrointestinal Neoplasms trials with a reported enrollment target (52% lower).

The record links to 1 condition, with Gastrointestinal Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Sunitinib is the first listed.

NCT07218926 names 20 study sites across 9 states, led by Other, Massachusetts, Nebraska.

Frequently Asked Questions

What is clinical trial NCT07218926 about?

NCT07218926 is a clinical study titled "A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy". 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 f...

What is the current status of trial NCT07218926?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2025-12-03. Estimated completion is 2030-11-29.

What conditions does trial NCT07218926 study?

This clinical trial studies the following conditions: Gastrointestinal Neoplasms.

What interventions are being tested in trial NCT07218926?

The interventions under investigation include: Sunitinib (DRUG), IDRX-42 (DRUG).

Who is sponsoring clinical trial NCT07218926?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07218926 being conducted?

This trial has 20 study locations across Massachusetts, Nebraska, New York, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Gastrointestinal Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07218926's enrollment target sits among peer trials

450 4th of 12 higher than 9 of 12 other Gastrointestinal Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gastrointestinal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07218926

Source: ClinicalTrials.gov NCT07218926, the US trial registry maintained by the National Library of Medicine. NCT07218926 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.