Papaverine with Chemoradiation for Stage II-III Non-Small Cell Lung Cancer
This study is looking at how safe and effective a drug called papaverine is when given with standard chemoradiation (chemotherapy and radiation therapy) for people with stage II-III non-small cell lung cancer. Papaverine aims to slow cancer growth by affecting how cancer cells use energy. Researchers hope that adding papaverine to chemoradiation, which includes drugs like carboplatin, paclitaxel, and durvalumab, might be a better way to treat this type of lung cancer. The study will also look at whether certain blood or tissue markers, and special MRI scans, can help predict who might benefit most from this treatment. You may be able to join if you are 18 or older and meet specific blood test requirements.
- Study design
- This is a dose-escalation study, meaning different doses of papaverine will be tested to find the safest and most effective amount. It plans to enroll 28 participants.
- What's involved
- You would receive papaverine either through a vein (IV) or under the skin (SC). If you are in the chemoradiation group, you would also have radiation therapy and receive carboplatin and paclitaxel through a vein.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of finding the best papaverine dose is measured at 6 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05136846
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentOhio State University Comprehensive Cancer CenterInvestigator-initiated
~28 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:CarboplatinDurvalumabPaclitaxelPapaverineRadiation TherapyPemetrexed
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT) or definitive hypofractionated radiation therapy
Measured over 6 weeks
Conditions
Where it's being run
2 sites across 2 statesCalifornia1
Ohio1
Study leadership
- Jeremey Brownstein, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\< grade 1 (except alopecia) at the time of enrollment
Absolute neutrophil count \>=1.5 x 10\^9/L
Hemoglobin \>= 9 g/dL
Platelets \>= 100 x 10\^9/L
Total bilirubin =\< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
Creatinine \< 1.5 mg/dL or calculated creatinine clearance\* \>= 50 mL/min or 24-hour urine creatinine clearance \>= 50 mL/min
Calculated by the Cockcroft-Gault formula •\>= 18 years old
Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
Clinical American Joint Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease.
For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive CRT or RT to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic tumor would be considered an additional site of disease with the exception of brain metastases. Up to 10 brain metastases would be considered as 1 site.
Patients with oligometastatic disease will be allowed to receive adjuvant systemic therapy at the discretion of the medical oncologist and additional local therapy to metastatic sites at the discretion of the multidisciplinary team
Patients must be considered unresectable or medically-inoperable if stage II-III NSCLC
Patients with a local or regional recurrence following surgical resection for whom definitive CRT or RT to disease in the chest is recommended by the multidisciplinary team will be considered eligible
Patients must have fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)-computed tomography (CT) scan (or CT chest/abdomen/pelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (preferred) or CT scan of the brain with contrast. Non-contrast MRI scans of the chest/abdomen/pelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency
Patients must have vital signs, history/physical examination, laboratory studies (complete blood count \[CBCP\] with differential, chemistries including liver function tests, creatinine clearance (CrCl) assessment; pregnancy test if needed within 14 days of registration)
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), glaucoma, or priapism
Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
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
Women/men of reproductive potential must be counselled on contraception/ abstinence while receiving the study treatment
Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 6 months after the last dose of radiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration
For patients planning to undergo CRT, patient is suitable to receive standard chemotherapy per treating medical oncologist with radiation during study treatment
Exclusion
Patients with history of pneumonectomy
History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
History of previous radiation therapy which would result in overlapping radiation fields
Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST/ALT)
Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study
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 treating physicians. This could include severe, active co-morbidities such as:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
Patients who are presently receiving nitrates or nitroglycerin, or have received these medications within 30 days of day 1 of protocol treatment
Patients who are currently taking Sildenafil should agree to discontinue use for 2 days prior to initiation of papaverine, during the duration of study, and for 2 days after last dose of papaverine
Any medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, pregnancy, nursing mothers, weight greater than 350 pounds)
Severe anxiety/claustrophobia related to MR imaging despite medications to relieve anxiety/claustrophobia
Patients who use supplemental oxygen and are not able to stop their oxygen for up to a few hours at a time, or who use oxygen because they have breathing when they are laying down
What this trial measures
- Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT) or definitive hypofractionated radiation therapy6 weeks
Will employ the Time-to-event Bayesian optimal interval design to find the MTD. Treatment-related toxicity will be assessed based on Common Terminology Criteria for Adverse Events version 5.0 criteria.