Thoracic CancerPhase 2NCT07843537
MINTER Trial: Metal Intervention aNd ThErapy With Radiotherapy In Thoracic Cancer Using Copper Donor Therapy: A Phase 2, Open-Label Study
A Phase 2 study testing Disulfiram 250 mg, Copper Gluconate 2 mg and Radiation Therapy in people with Thoracic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study is being done to test whether adding two drugs-disulfiram and copper gluconate-to radiation therapy can help overcome this resistance and improve treatment outcomes. When disulfiram is combined with copper, it forms a substance that may increase stress within cancer cells and lead to a specific type of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Cancer
- What is being tested?
- Disulfiram 250 mg, Copper Gluconate 2 mg and Radiation Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Mar 2032
- Phase
- Phase 2
- 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
- Histologically confirmed locally advanced or metastatic disease of any histology that will receive chest radiation
- Scheduled to receive RT as part of definitive local consolidation therapy (LCT) (not palliative)
- Induction systemic therapy allowed, but just not concurrently given (washout for at least 3 weeks before start of CDT and RT)
- Age ≥18 years.
- ECOG 0-2.
- Adequate organ and marrow function within 28 days prior to enrollment defined as:
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- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L
- Hemoglobin ≥9 g/dL
- Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL/min
- Total bilirubin ≤1.5 × ULN (≤3 × ULN for patients with known Gilbert's syndrome)
- AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with hepatic metastases)
- Ability to provide written informed consent.
- Prior thoracic radiation allowed as long as cumulative organ as risk constraints are met
Who cannot join
- Uncontrolled intercurrent illness.
- Known hypersensitivity to Disulfiram.
- Contraindications to radiation therapy.
- Inability to stay away from alcohol products during the use of Disulfiram.
- Wilson's Disease (copper overload disorder)
- Hepatic dysfunction with AST/ALT/bilirubin levels that are outside 2.5 X normal range (≤2.5 × ULN)
- Hypersensitivity to copper-containing compounds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Steven Lin, MD, PHD, 713-563-8490, shlin@mdanderson.org
Steven Lin, MD, PHD
About this study
This study is being done to test whether adding two drugs-disulfiram and copper gluconate-to radiation therapy can help overcome this resistance and improve treatment outcomes. When disulfiram is combined with copper, it forms a substance that may increase stress within cancer cells and lead to a specific type of cancer cell death knowns as "cuproptosis".
Read the detailed description
Primary Objectives:
- Evaluate the safety and feasibility of CDT (disulfiram + copper gluconate) during RT in patients undergoing radiotherapy within the thorax.
- Evaluate the progression free survival (PFS) time.
Secondary Objectives:
- Monitor all treatment-related adverse events from CDT during RT.
- Assess local control (LC) at 6 months.
Exploratory Objectives:
- Evaluate cuproptosis-related gene expression and biomarkers of copper metabolism in the baseline biopsy tissues and associate with treatment response. We aim to identify cuproptosis gene signatures (e.g., FDX1, LIAS, DLAT, PDHA1, MT1E, MT1X) as predictive biomarkers of therapeutic response.
- Evaluate the potential for continued CDT during adjuvant immunotherapy
- Conditions
- Thoracic Cancer
- Being tested
- Disulfiram 250 mg, Copper Gluconate 2 mg, Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disulfiram 250 mgDrug
Also called Antabuse
Given orally once daily
Copper Gluconate 2 mgDrug
Given orally three times daily
Radiation TherapyDrug
Delivered per institutional standards (radiotherapy alone in 10-15 fractions as local consolidation therapy).
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Disulfiram + Copper Gluconate + Concurrent LCT | Experimental | Not described Receives: Drug: Disulfiram 250 mg; Drug: Copper Gluconate 2 mg; Drug: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Lin, MD, PHD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843537
- Sponsor's protocol ID
- 2025-1499
- Other IDs
- NCI-2026-07038
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINTER Trial: Metal Intervention aNd ThErapy With Radiotherapy In Thoracic Cancer Using Copper Donor Therapy: A Phase 2, Open-Label Study
- ClinicalTrials.gov ID
- NCT07843537
- Acronym / sponsor ID
- 2025-1499
- Conditions
- Thoracic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Mar 2032 (estimated)
- First posted
- 28 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 study is being done to test whether adding two drugs-disulfiram and copper gluconate-to radiation therapy can help overcome this resistance and improve treatment outcomes. When disulfiram is combined with copper, it forms a substance that may increase stress within cancer cells and lead to a specific type of cancer cell death knowns as "cuproptosis".
Detailed description
Primary Objectives:
- Evaluate the safety and feasibility of CDT (disulfiram + copper gluconate) during RT in patients undergoing radiotherapy within the thorax.
- Evaluate the progression free survival (PFS) time.
Secondary Objectives:
- Monitor all treatment-related adverse events from CDT during RT.
- Assess local control (LC) at 6 months.
Exploratory Objectives:
- Evaluate cuproptosis-related gene expression and biomarkers of copper metabolism in the baseline biopsy tissues and associate with treatment response. We aim to identify cuproptosis gene signatures (e.g., FDX1, LIAS, DLAT, PDHA1, MT1E, MT1X) as predictive biomarkers of therapeutic response.
- Evaluate the potential for continued CDT during adjuvant immunotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Disulfiram + Copper Gluconate + Concurrent LCT | Experimental | Drug: Disulfiram 250 mg, Drug: Copper Gluconate 2 mg, Drug: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed locally advanced or metastatic disease of any histology that will receive chest radiation
- Scheduled to receive RT as part of definitive local consolidation therapy (LCT) (not palliative)
- Induction systemic therapy allowed, but just not concurrently given (washout for at least 3 weeks before start of CDT and RT)
- Age ≥18 years.
- ECOG 0-2.
Key exclusion criteria (7 listed)
- Uncontrolled intercurrent illness.
- Known hypersensitivity to Disulfiram.
- Contraindications to radiation therapy.
- Inability to stay away from alcohol products during the use of Disulfiram.
- Wilson's Disease (copper overload disorder)
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 |
|---|---|---|
| Disulfiram 250 mgAlso: AntabuseGiven orally once daily | Drug | Treatment with Disulfiram + Copper Gluconate + Concurrent LCT |
| Copper Gluconate 2 mgGiven orally three times daily | Drug | Treatment with Disulfiram + Copper Gluconate + Concurrent LCT |
| Radiation TherapyDelivered per institutional standards (radiotherapy alone in 10-15 fractions as local consolidation therapy). | Drug | Treatment with Disulfiram + Copper Gluconate + Concurrent LCT |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
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 28 Sep 2026.
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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.
Steven Lin, MD, PHD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disulfiram 250 mg, Copper Gluconate 2 mg and Radiation Therapy in people with Thoracic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 14 inclusion and 7 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Steven Lin, MD, PHD ((713) 563-8490, shlin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 28 Sep 2026.