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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: ogarrieta@gmail.com
• Phone: +525556280400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Osimertinib with Early Stereotactic Radiosurgery for EGFR Mutated NSCLC with Brain Metastases

  This study is testing if combining a lung cancer drug called Osimertinib with early targeted radiation therapy can help people with EGFR-mutated non-small cell lung cancer and brain metastases live longer and maintain better brain function.

  Recruiting Hadassah Medical Organization · Jerusalem · NCT05033691

• Datopotamab-deruxtecan with carboplatin and pembrolizumab for treatment‑naive NSCLC that has spread to the brain

  This trial will try giving datopotamab-deruxtecan together with carboplatin and pembrolizumab to adults with metastatic non‑small cell lung cancer that has spread to the brain and has no targetable mutations.

  Recruiting at 13 sites Phase 2 Latin American Cooperative Oncology Group · Fortaleza, Ceará and 12 other locations · NCT06822543

• Combining Cadonilimab with Stereotactic Radiotherapy for Brain Metastases Treatment

  This study is testing if combining a new drug called Cadonilimab with targeted radiation therapy can help people with brain metastases from lung cancer feel better and have fewer side effects than current treatments.

  Recruiting Phase 2 Xiangya Hospital of Central South University · Changsha, Hunan · NCT06702826

• Combining SRT and Anlotinib for treating brain metastases from lung cancer

  This study is testing if combining a targeted cancer drug called Anlotinib with a type of focused radiation therapy can help patients with non-small cell lung cancer who have limited brain metastases and haven't responded to other treatments.

  Recruiting The First People's Hospital of Lianyungang · Lianyungang, Jiangsu · NCT06476093

• Combining Nintedanib with EGFR inhibitors for advanced lung cancer

  This study is testing if combining a medication called Nintedanib with EGFR inhibitors can help people with advanced lung cancer who haven't responded to previous treatments.

  Recruiting Phase 1/2 China Medical University Hospital · Taichung · NCT06071013

• Evaluating BDTX-4933 for patients with specific cancer mutations

  This study is testing a new drug called BDTX-4933 to see if it can help adults with advanced cancers that have certain gene mutations feel better and improve their treatment options.

  Recruiting at 34 sites Phase 1/2 Servier · Gilbert, Arizona and 48 other locations · NCT05786924

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.