NIPH Clinical Trials Search

A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Previously untreated metastatic and/or unresectable gastrointestinal stromal tumors (GIST)
Date of first enrollment	27/07/2026
Target sample size	64
Countries of recruitment	Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Italy,Japan,Republic of Korea,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Saudi Arabia,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,Turkiye,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	This is a Phase 3, randomized, multicenter, open-label study in participants with previously untreated metastatic and/or unresectable gastrointestinal stromal tumors (GIST). Participants will be randomized in a 1:1 ratio to one of the following treatment arms: -Velzatinib arm: velzatinib 300 mg orally once daily, administered continuously in 28-day cycles -Imatinib arm: imatinib 400 mg orally once daily, administered continuously in 28-day cycles Participants in the imatinib arm identified as harboring KIT exon 9 mutations may escalate the imatinib dose up to 800 mg/day based on investigator judgment and tolerability. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or other protocol-defined discontinuation criteria.

Outcome(s)

Primary Outcome

Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to mRECIST-GIST

Secondary Outcome

Key Secondary Endpoints -Confirmed Objective Response Rate (ORR) according to mRECIST-GIST as assessed by BICR -Overall Survival (OS) -Additional Secondary Endpoints -Confirmed ORR according to mRECIST-GIST by investigator assessment -Progression-Free Survival (PFS) by investigator assessment -Progression-Free Survival 2 (PFS2) -Duration of Response (DOR) -Time to Response (TTR) -Time to Second Subsequent Therapy (TSST) -Safety and tolerability including incidence and severity of TEAEs and SAEs, dose reductions, interruptions, and discontinuations -Plasma concentrations of velzatinib (PK) -Health-related quality of life assessed by EORTC QLQ-C30 -Symptomatic adverse events and tolerability assessed by PRO-CTCAE and FACT-GP5

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Participant is at least 18 years of age or the legal age of consent at the time of signing the informed consent form (ICF). Histologically or cytologically confirmed gastrointestinal stromal tumor (GIST) that is metastatic and/or surgically unresectable. No prior systemic therapy for metastatic and/or unresectable GIST. Participants who previously received neoadjuvant and/or adjuvant imatinib for localized GIST are eligible provided that at least 6 months have elapsed since the last imatinib dose prior to diagnosis of metastatic and/or unresectable disease. Documented KIT and/or PDGFRA mutation status assessed by tissue-based next-generation sequencing prior to enrollment. Availability of tumor tissue sample (archival preferred or fresh biopsy obtained as part of standard of care). At least 1 target lesion according to mRECIST-GIST. ECOG Performance Status <-1. Adequate organ function as defined in the protocol. Willingness to comply with protocol-defined contraceptive requirements. Capable of providing signed informed consent.
Exclude criteria	GIST known to be both KIT and PDGFRA wild-type, or harboring activating PDGFRA exon 18 mutation. Malignancy other than the disease under study that has progressed or required active treatment within the past 24 months, with specified exceptions. Clinically significant gastrointestinal abnormalities that may alter drug absorption (e.g., malabsorption syndrome or major gastrointestinal resection). Major surgery within 14 days prior to first dose of study treatment or incomplete recovery from surgery. Prior allogeneic/autologous bone marrow transplantation or solid organ transplantation. Known hypersensitivity to velzatinib or imatinib. Clinically significant or uncontrolled cardiovascular disease within 6 months prior to enrollment. Untreated or progressive brain/CNS metastases. Ongoing toxicities from prior therapy that have not recovered to <-Grade 1 or baseline (except specified conditions). Active renal disease requiring dialysis or other clinically significant renal disorder. Serious or unstable medical or psychiatric condition that may interfere with study participation. Radiotherapy within 14 days prior to first dose of study treatment. Receipt of moderate or strong P-gp and/or BCRP inhibitors or inducers within protocol-defined washout periods. Positive drug or alcohol screening. HIV infection meeting protocol-defined exclusion criteria. Unable to swallow or retain oral medication. Pregnant or breastfeeding. ALT, bilirubin, INR, or QTc findings meeting protocol-defined exclusion criteria.