Combining nitroglycerin with radiation therapy for lung cancer patients with brain metastases

A Phase III Study Comparing Concurrent Nitroglycerin With Radiation Therapy vs Radiation Therapy Alone in Patients With Non-small Cell Lung Cancer With EGFR Mutations and Brain Metastases.

This study is testing if adding nitroglycerin to radiation therapy can help lung cancer patients with brain metastases live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Instituto Nacional de Cancerologia de Mexico (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT06238882 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of adding transdermal nitroglycerin to total cranial radiation therapy in patients with stage IV non-small cell lung cancer who have brain metastases and an EGFR mutation. The study aims to determine the intracranial response rate, progression-free survival, overall survival, and quality of life during and after treatment. Participants will undergo laboratory tests and cranial MRIs to assess treatment outcomes and cognitive function. The trial seeks to address the challenge of radio-resistance in brain metastases by using nitroglycerin as a nitric oxide generator.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced non-small cell lung cancer, brain metastases, and documented EGFR sensitivity mutations.

Not a fit: Patients who are not candidates for cranial radiation therapy or those with contraindications to vasodilator treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with advanced lung cancer and brain metastases.

How similar studies have performed: Previous studies have indicated that combining nitroglycerin with radiation therapy may enhance treatment response, particularly in patients with EGFR mutations, suggesting a promising avenue for further investigation.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with advanced non-small cell lung cancer (which includes de novo stage IIIB-IV, according to the 8th edition AJCC, or recurrent disease), documented by histology and/or cytology.
* Presence of brain metastases, candidates for treatment with holocranial radiation therapy.
* Documented EGFR sensitivity mutation.
* Disease measurable by criteria: The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
* 18 years and up.
* Functional status, by ECOG scale 0-2
* Life expectancy at least 12 weeks.
* Not receive vasodilator treatment as calcium channel blockers.
* Electrocardiogram
* Neutrophil count 1.5 x 103/mm3, platelet count \>100 x (103/mm3).
* Serum bilirubin should be 1.5 of the upper normal limit (ULN, upper normal limit).
* AST and/or ALT 2 ULN (or 5 x ULN in patients with liver metastases).
* Serum creatinine 1.5 (ULN), or creatinine clearance 60ml/min.
* Ability to comply with study and follow-up procedures.
* Informed written (signed) consent to participate in the study.
* Have tumor tissue (paraffin blocks from diagnostic biopsy) obtained before systemic treatment

Exclusion Criteria:

* Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, ischemic heart disease, liver, kidney disease).
* Patients with a history of allergy to glyceryl tinistate
* Any other malignant pathology within the previous 5 years (except for cervical carcinoma in situ or basal-cell skin cancer, treated appropriately).
* Pregnant and/or breastfeeding women.
* Meningeal carcinomatosis corroborated by cytopathological study.

Disposal Criteria:

* Failure to follow protocol rules.
* Loss of patient follow-up.
* Patients who express their desire not to continue the study.
* Patients with unacceptable toxicity

Where this trial is running

Mexico City, Mexico City

• Instituto Nacional de Cancerologia — Mexico City, Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: Oscar G Arrieta, M.D., M.Sc. — Instituto Nacional de Cancerologia de Mexico
• Study coordinator: Oscar G Arrieta, M.D., M.Sc.

Conditions Non-small Cell Lung Cancer; Brain Metastases; EGFR Gene Mutation; Radiation therapy; Nitroglycerin; Brain metastases; EGFR mutation; Non-small cell lung cancer