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Compares treatment options for Non-small Cell Lung Cancer
Official title Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.
ClinicalTrials.gov ID: NCT06238882
What this study is testing
What is Nitroglycerin?
Nitroglycerin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Minitran® Patch.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this interventional phase III clinical trial is to evaluate objective intracranial response rate (iORR) after a treatment with total cranial radiation therapy plus concomitant transdermal nitroglycerin (NTG) addition or total cranial radiation therapy only in patients with stage IV non-small cell lung cancer with brain metastases and EGFR mutation. The main questions it aims to answer are: Determine progression-free survival (PFS) to CNS and overall survival (OS).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patients diagnosed with advanced non-small cell lung cancer (which includes de novo stage IIIB-IV, according to the 8th edition AJCC, or recurrent...
- 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.
You likely can't join if
- Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, ischemic heart 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.