NCT07824986Not yet recruitingPhase 3
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 · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 May 2028
- Lead sponsor
- Vivace Therapeutics, Inc
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT07824986
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 350
- From 1 Dec 2026 to the primary completion date, 1 May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents
- 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.
Other illness
- 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
Lab values
- Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula).
Other
- Active brain metastases or primary CNS (central nervous system) tumors.
- Women who are pregnant or breastfeeding
- Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.