RecruitingPhase 1NCT05136846

Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer

A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

28 participants

Start Date

Dec 6, 2021

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Unresectable Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8

Summary

This phase I trial finds out the best dose, possible benefits and/or side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding papaverine (a drug that relaxes blood vessel walls and may improve tumor oxygenation) to standard chemotherapy and radiation can improve outcomes for patients with stage II or III non-small cell lung cancer. **You may be eligible if...** - You have stage II or III non-small cell lung cancer - You are in reasonably good health with adequate blood counts, liver, and kidney function - Any side effects from previous treatments have mostly resolved **You may NOT be eligible if...** - You have severe organ dysfunction (liver, kidneys, bone marrow) - You have previously received certain treatments that would exclude you - Your blood counts are too low to safely receive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Given IV

BIOLOGICALDurvalumab

Given IV

DRUGPaclitaxel

Given IV

DRUGPapaverine

Given IV or SC

RADIATIONRadiation Therapy

Undergo RT

DRUGPemetrexed

Given IV

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated RT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREComputed Tomography

Undergo PET/CT or CT

PROCEDUREMagnetic Resonance Imaging of the Brain with and without Contrast

Undergo brain MRI

PROCEDUREBiospecimen Collection

Undergo blood sample collection

Locations(2)

City of Hope

Duarte, California, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT05136846

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