Lung Non-Small Cell CarcinomaPhase 1NCT03824327

Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases

A Phase 1 study testing Blood Oxygen Level Dependent Imaging, Papaverine Hydrochloride and Stereotactic Body Radiation Therapy in people with Lung Non-Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Non-Small Cell Carcinoma
What is being tested?: Blood Oxygen Level Dependent Imaging, Papaverine Hydrochloride and Stereotactic Body Radiation Therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 7 Feb 2019to 31 Jul 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Show all 15Show fewer

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)

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases

This phase I trial studies the side effects and how well papaverine hydrochloride and stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung cancer. Papaverine hydrochloride may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the safety and tolerability of concurrent papaverine hydrochloride (PPV), and lung SBRT in patients with non-small cell lung cancer (NSCLC) or lung metastases.

SECONDARY OBJECTIVES:

To assess primary tumor control rate, local control rate, local-regional recurrence free-survival (LRRFS), disease-free survival (DFS), distant-metastasis-free survival (DMFS), and overall survival (OS).

II. To assess whether blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (MRI) studies can predict which patients may respond best to PPV + SBRT, and detect changes in oxygenation before and after PPV administration.

III. To assess whether blood-based micro ribonucleic acid (miRNA) biomarkers can predict which patients may respond best to PPV + SBRT.

OUTLINE: This is a dose-escalation study of papaverine hydrochloride.

Patients undergo BOLD functional magnetic resonance imaging (fMRI) and receive papaverine hydrochloride intravenously (IV) on day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks.

After completion of study treatment, patients are followed up at 4-6 weeks, 3 and 6 months, 1 and 2 years, then every 3 months for 2 years, and then every 6 months for 3 years.

Conditions: Lung Non-Small Cell Carcinoma
Being tested: Blood Oxygen Level Dependent Imaging, Papaverine Hydrochloride, Stereotactic Body Radiation Therapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood Oxygen Level Dependent ImagingProcedure or surgery
Also called Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging, BOLD, BOLD fMRI
Undergo BOLD fMRI
Papaverine HydrochlorideDrug
Also called Cerebid, Cerespan, Pap H, Pavabid
Given IV
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT

Study groups in NCT03824327
Study group	Role	What they receive
Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)	Experimental	Patients undergo BOLD fMRI and receive papaverine hydrochloride IV on days -7 to day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks. Patients undergo CT scan throughout the study and blood sample collection on study. Receives: Procedure: Blood Oxygen Level Dependent Imaging; Drug: Papaverine Hydrochloride; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum-tolerated dose (MTD)
Will employ the Bayesian optimal interval (BOIN) design to find the MTD.
Measured: Up to 2 weeks

Secondary outcomes (8)

Primary tumor control
Primary tumor control is defined as the absence of primary tumor failure. Will be calculated and 95% exact binomial confidence interval will be provided.
Measured: At 12 and 24 months after stereotactic body radiation therapy (SBRT) completion
Local control rate (primary tumor control + involved lobar control)
Local control is defined as the absence of local failure. Will be calculated and 95% exact binomial confidence interval will be provided.
Measured: Up to 12 months after SBRT completion
Local-regional recurrence free-survival
Will be summarized using Kaplan-Meier method.
Measured: From time of entry onto study until the time of documented local-regional recurrence or death, assessed up to 12 months after SBRT completion
Distant metastasis-free survival
Will be summarized using Kaplan-Meier method.
Measured: Time from entry onto study until the time of documented metastatic recurrence or death, assessed up to 12 months after SBRT treatment
Disease-free survival
Will be summarized using Kaplan-Meier method.
Measured: Time from entry onto study until the time of any documented disease recurrence or death, assessed up to 12 months after SBRT completion
Overall survival
Will be summarized using Kaplan-Meier method.
Measured: Time from study entry until time of death from any cause, assessed up to 12 months after SBRT completion
Changes in magnetic resonance imaging (MRI) blood oxygen level-dependent (BOLD) response
Will be measured before and after papaverine hydrochloride (PPV) delivery by the percentage change in relaxation rate on MRI. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of analysis of variance (ANOVA) for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.
Measured: Up to 4 hours
Change in hypoxia-inducible micro ribonucleic acids (miRNAs)
Will analyze patient serum pre-and post-treatment for hypoxia-associated at pre- and post- SBRT treatment hypoxia-inducible microRNAs (miRs) using nanoString miRNA assay that could indicate the presence of tumor hypoxia. The changes in circulating biomarkers will be validated by alternative quantitative polymerase chain reaction (qPCR) based approaches. These results will be cross-validated with the BOLD data. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of ANOVA for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.
Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 201931 Jul 2027

First posted31 Jan 2019
Study start7 Feb 2019
Primary completion31 Oct 2025
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03824327
Sponsor's protocol ID: OSU-18215
Other IDs: NCI-2019-00105
Status last verified: Oct 2026
First submitted: 23 Jan 2019
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases
ClinicalTrials.gov ID: NCT03824327
Acronym / sponsor ID: OSU-18215
Conditions: Lung Non-Small Cell Carcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 19 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Study start: 7 Feb 2019 (actual)
Primary completion: 31 Oct 2025 (actual)
Study completion: 31 Jul 2027 (estimated)
First posted: 31 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the safety and tolerability of concurrent papaverine hydrochloride (PPV), and lung SBRT in patients with non-small cell lung cancer (NSCLC) or lung metastases.

SECONDARY OBJECTIVES:

To assess primary tumor control rate, local control rate, local-regional recurrence free-survival (LRRFS), disease-free survival (DFS), distant-metastasis-free survival (DMFS), and overall survival (OS).

III. To assess whether blood-based micro ribonucleic acid (miRNA) biomarkers can predict which patients may respond best to PPV + SBRT.

OUTLINE: This is a dose-escalation study of papaverine hydrochloride.

After completion of study treatment, patients are followed up at 4-6 weeks, 3 and 6 months, 1 and 2 years, then every 3 months for 2 years, and then every 6 months for 3 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)	Experimental	Procedure: Blood Oxygen Level Dependent Imaging, Drug: Papaverine Hydrochloride, Radiation: Stereotactic Body Radiation TherapyPatients undergo BOLD fMRI and receive papaverine hydrochloride IV on days -7 to day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks. Patients undergo CT scan throughout the study and blood sample collection on study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (8 listed)

History of another malignancy
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood Oxygen Level Dependent ImagingAlso: Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging, BOLD, BOLD fMRIUndergo BOLD fMRI	Procedure or surgery	Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)
Papaverine HydrochlorideAlso: Cerebid, Cerespan, Pap H, PavabidGiven IV	Drug	Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)
Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT	Radiation	Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)

Primary outcome

Maximum-tolerated dose (MTD)
Time frame: Up to 2 weeks
Will employ the Bayesian optimal interval (BOIN) design to find the MTD.

8 secondary outcomes

Primary tumor control
Time frame: At 12 and 24 months after stereotactic body radiation therapy (SBRT) completion
Local control rate (primary tumor control + involved lobar control)
Time frame: Up to 12 months after SBRT completion
Local-regional recurrence free-survival
Time frame: From time of entry onto study until the time of documented local-regional recurrence or death, assessed up to 12 months after SBRT completion
Distant metastasis-free survival
Time frame: Time from entry onto study until the time of documented metastatic recurrence or death, assessed up to 12 months after SBRT treatment
Disease-free survival
Time frame: Time from entry onto study until the time of any documented disease recurrence or death, assessed up to 12 months after SBRT completion
Overall survival
Time frame: Time from study entry until time of death from any cause, assessed up to 12 months after SBRT completion
Changes in magnetic resonance imaging (MRI) blood oxygen level-dependent (BOLD) response
Time frame: Up to 4 hours
Change in hypoxia-inducible micro ribonucleic acids (miRNAs)
Time frame: Up to 3 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Lung Non-Small Cell Carcinoma

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeremy Brownstein, MD principal investigator

Ohio State University Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum-tolerated dose (MTD) (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03824327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.