Could a common drug make radiation deadlier to lung tumors?
NCT ID NCT03824327
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding a drug called papaverine to precise, high-dose radiation (SBRT) can help control non-small cell lung cancer. About 19 patients with a single lung tumor will receive both treatments. The main goal is to find the safest dose and see if the combination improves tumor control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Papaverine hydrochloride (a drug that may make cancer cells more sensitive to radiation)
- What this could lead to
- If it works, this could point toward a way to make radiation therapy more effective for lung cancer, potentially improving tumor control.
- What could go wrong
- This is a very early (Phase I) trial with only 19 participants, so it is primarily testing safety and dosing. It may not show a clear benefit, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
19 people
The number who actually took part.
- Started
-
Feb 2019
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically proven NSCLC for whom SBRT to a single lesion has been chosen as the primary treatment modality (planned dose 50 Gy in 4-5 daily fractions). Patients with lung metastases from solid tumors are eligible. * Patients must have a tumor =\< 5 cm as defined by computed tomography (CT) largest axial dimension. Presence of adjacent nodules considered neoplastic in the same lobe or other ipsilateral lobe are allowed as long as the nodule(s) can be encompassed in an SBRT gross tumor volume (GTV) of =\< 5 cm, within 1 isocenter. Multiple isocenters are not allowed * No prior radiation resulting in overlapping fields * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Must be able to undergo correlative research MRIs * No active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis (IPF) * No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism * Within 30 days of registration: patients must have vital signs, history/physical examination, and laboratory studies (liver function tests, creatinine or creatinine clearance assessment) * Life expectancy of at least 12 weeks in the opinion of investigator * Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment. Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen * Within 90 days of registration: pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV-1) and diffusion capacity of the lung for carbon monoxide (DLCO) * Albumin \>= 2.5 g/dL (within 30 days of study registration) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (within 30 days of study registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (within 30 days of study registration) * Creatinine =\< 1.5 x ULN or calculated creatinine \>= 50 mL/min, calculated by the Cockcroft-Gault formula or 24-hour urine creatinine clearance \>= 50 mL/min (within 30 days of study registration) Exclusion Criteria: * History of another malignancy * Exception: Subjects who have been disease-free for \>= 3 years, or subjects with a history of localized prostate cancer, in situ carcinoma (e.g. breast, cervix, oral cavity), differentiated thyroid neoplasm, completely resected non-melanoma skin cancer, are eligible * Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator * Pregnancy or breastfeeding: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and for 4 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. No breastfeeding while patient is on study * Patients with history of pneumonectomy * Prior cytotoxic chemotherapy, molecularly-targeted agents (e.g. erlotinib, crizotinib), or immunotherapy unless \>= 2 weeks from last dose. Patients can start chemotherapy, immunotherapy, or other systemic therapy after completion of SBRT, but this should be planned for ≥ 2 weeks from last SBRT dose. * History of active connective tissue disease (scleroderma), idiopathic pulmonary fibrosis, pneumonitis * Hepatic insufficiency resulting in jaundice and/or coagulation defects, or not meeting laboratory values (albumin, total bilirubin, AST/ALT)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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