Clinical trial · Interventional
A Phase 3 Trial in Advanced Epithelioid Mesothelioma
A Phase 3, Randomized, Open-label Trial Comparing VT3989 Versus Gemcitabine or Vinorelbine in Participants With Advanced Epithelioid Mesothelioma, Who Previously Received Platinum-Based Systemic Chemotherapy and Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
| VT3989 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - VT3989
- description
- VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.
- interventionNames
- Drug: VT3989
- type
- ACTIVE_COMPARATOR
- label
- Arm B - Investigator's Choice Chemotherapy
- description
- The Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice.
- interventionNames
- Drug: gemcitabine
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, age 18 years or older at informed consent. * Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently. * Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1. * ECOG: 0-1. * Adequate organ functions, including the liver, kidneys, and hematopoietic system. Exclusion Criteria: * Active brain metastases or primary CNS (central nervous system) tumors. * History of leptomeningeal metastases * Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Known HIV positive or active Hepatitis B or Hepatitis C * Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents * Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula). * Women who are pregnant or breastfeeding * Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma. * Prior treatment with a TEAD inhibitor, including VT3989 or another agent targeting the same molecular pathway. * Prior receipt of both comparator treatments, gemcitabine and vinorelbine, alone or in combination, or known hypersensitivity to both. A participant who received only one comparator may enroll but must not be assigned to that same comparator.
References
Publications (0)
Data not yet available