NCT07843537

Brief 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 cancer cell death knowns as "cuproptosis".

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
62mo left

Started Mar 2027

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2030

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2032

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion; an average of 1 year

Study Arms (1)

Treatment with Disulfiram + Copper Gluconate + Concurrent LCT

EXPERIMENTAL
Drug: Disulfiram 250 mgDrug: Copper Gluconate 2 mgDrug: Radiation Therapy

Interventions

Given orally once daily

Also known as: Antabuse
Treatment with Disulfiram + Copper Gluconate + Concurrent LCT

Given orally three times daily

Treatment with Disulfiram + Copper Gluconate + Concurrent LCT

Delivered per institutional standards (radiotherapy alone in 10-15 fractions as local consolidation therapy).

Treatment with Disulfiram + Copper Gluconate + Concurrent LCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

DisulfiramGluconatesRadiotherapy

Intervention Hierarchy (Ancestors)

DitiocarbThiocarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsDisulfidesSulfidesSulfur CompoundsSugar AcidsHydroxy AcidsCarbohydratesTherapeutics

Study Officials

  • Steven Lin, MD, PHD

    UT MD Anderson

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Lin, MD, PHD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 28, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 30, 2030

Study Completion (Estimated)

March 30, 2032

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations