Clinical trial · Interventional
Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
Phase II Trial Evaluating the Addition of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pending resolution of study drug issues
Summary
Brief summary (as posted)
This is a randomized, double blind placebo controlled study to evaluate safety and efficacy of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lucanthone | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- WBRT + Lucanthone
- description
- Treatment will consist of WBRT given in a dose of 30 Gy in ten fractions with lucanthone given as an adjunct. Lucanthone will be administered as 25 mg and 100 mg tablets to be swallowed. Dosage will be one of the following: 250 mg bid, 250 tid, or 375 mg tid.
- interventionNames
- Drug: Lucanthone
- type
- PLACEBO_COMPARATOR
- label
- WBRT + Placebo
- description
- Patients will receive prophylactic cranial irradiation at 3 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 30 Gy.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Determine the efficacy of lucanthone when given during WBRT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has given informed consent. * The patient is willing and able to abide by the protocol. * The patient is between age 18 and 70 (between 19 and 70 in Alabama). * The patient has histologically proven NSCLC with radiologically documented brain metastases. * Newly diagnosed or stable systemic disease, on or off systemic therapy. * If receiving systemic therapy for NSCLC, at least two weeks since patient received systemic therapy. * Able to withhold systemic therapy for duration of WBRT therapy. * If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception. * The patient's Karnofsky Score is greater than or equal to 70%. Exclusion Criteria: * Patient has a diagnosis of recurrent brain metastases. * The patient has an absolute neutrophil count less than or equal to 1.5 X 10 9/L. * The patient has a screening platelet count less than 100,000/uL. * The patient has a screening bilirubin greater than 1.6 mg/dL. * The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women. * The patient has a screening ALT/AST greater than 2.5 times the upper limit of the laboratory reference range. * The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study. * The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product. * The patient has received prior chemotherapy or radiation therapy within two weeks of beginning WBRT on protocol. * The patient is allergic to gadolinium contrast. * More than 21 days has or will elapse between the brain MRI documenting the brain metastases and the initiation of WBRT.
References
Publications (0)
Data not yet available