Pleural MesotheliomaPhase 3sTEADfastNCT07824986
A Phase 3 Trial in Advanced Epithelioid Mesothelioma
A Phase 3 study testing VT3989, gemcitabine and Vinorelbine in people with Pleural Mesothelioma and Mesothelioma, run by Vivace Therapeutics, Inc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelioma, Mesothelioma
- What is being tested?
- VT3989, gemcitabine and Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B).
VT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing/institutional practice.
The trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.
- Conditions
- Pleural Mesothelioma, Mesothelioma
- Being tested
- VT3989, gemcitabine, Vinorelbine
- Keywords
- Mesothelioma
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT3989Drug
- 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
gemcitabineDrug
- 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
VinorelbineDrug
- 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
| Study group | Role | What they receive |
|---|---|---|
| Arm A - VT3989 | Experimental | VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason. Receives: Drug: VT3989 |
| Arm B - Investigator's Choice Chemotherapy | Active comparator | The Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice. Receives: Drug: gemcitabine; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.
Measured: Approximately 32-35 months after first randomization
Secondary outcomes (10)
Progression-Free Survival by BICR
Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.
Measured: From randomization through radiologic progression, death, up to approximately 3 years or more
Treatment-Emergent Adverse Events and Serious Adverse Events
Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events
Measured: From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
Disease-related symptoms and health-related quality of life outcomes
Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.
Measured: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Overall Response Rate by BICR
Overall Response Rate by BICR Proportion with best overall response of complete response or partial response by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Measured: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Duration of Response
Among participants with a complete or partial response, time from first documented response to progressive disease or death, with protocol-defined censoring.
Measured: From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
Disease Control Rate by BICR
Proportion with best overall response of complete response, partial response, or stable disease by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Measured: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Time to Response
Time from randomization to the first documented complete or partial response by RECIST v1.1 and/or modified RECIST v1.1.
Measured: From randomization to first documented response; up to approximately 3 years or more
EORTC QLQ-LC13
Lung cancer- and treatment-related symptoms using the EORTC Quality of Life Questionnaire Lung Cancer Module 13.
Measured: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
EQ-5D-5L
Health status and health-related quality of life using the EuroQol 5 Dimension-5 Levels instrument.
Measured: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Time to Deterioration
Time to protocol-defined deterioration in disease-related symptoms and health-related quality of life; detailed definition will be specified in the Statistical Analysis Plan.
Measured: From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to VT3989 or Investigator's choice chemotherapy (gemcitabine or vinorelbine).
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivace Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824986
- Sponsor's protocol ID
- VT3989-003
- Acronym
- sTEADfast
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07824986
- Acronym / sponsor ID
- sTEADfast / VT3989-003
- Conditions
- Pleural Mesothelioma, Mesothelioma
- Keywords
- Mesothelioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Vivace Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B).
VT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing/institutional practice.
The trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to VT3989 or Investigator's choice chemotherapy (gemcitabine or vinorelbine).
| Arm | Type | Receives |
|---|---|---|
| Arm A - VT3989 | Experimental | Drug: VT3989VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason. |
| Arm B - Investigator's Choice Chemotherapy | Active comparator | Drug: gemcitabine, Drug: VinorelbineThe Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT3989• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle | Drug | Arm A - VT3989 |
| gemcitabine• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice | Drug | Arm B - Investigator's Choice Chemotherapy |
| Vinorelbine• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice | Drug | Arm B - Investigator's Choice Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: Approximately 32-35 months after first randomization
Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.
10 secondary outcomes
Progression-Free Survival by BICR
Time frame: From randomization through radiologic progression, death, up to approximately 3 years or more
Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
Disease-related symptoms and health-related quality of life outcomes
Time frame: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Overall Response Rate by BICR
Time frame: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Duration of Response
Time frame: From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
Disease Control Rate by BICR
Time frame: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Time to Response
Time frame: From randomization to first documented response; up to approximately 3 years or more
EORTC QLQ-LC13
Time frame: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
EQ-5D-5L
Time frame: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Time to Deterioration
Time frame: From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VT3989, gemcitabine and Vinorelbine in people with Pleural Mesothelioma and Mesothelioma, run by Vivace Therapeutics, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arick Wong (650-666-2753, vt3989-003@vivacetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Approximately 32-35 months after first randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.