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

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.

Conditions

• Locally Advanced Lung Non-Small Cell Carcinoma
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• 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

Interventions

DRUG

Carboplatin

Given IV

BIOLOGICAL

Durvalumab

Given IV

DRUG

Paclitaxel

Given IV

DRUG

Papaverine

Given IV or SC

RADIATION

Radiation Therapy

Undergo RT

DRUG

Pemetrexed

Given IV

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated RT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Computed Tomography

Undergo PET/CT or CT

PROCEDURE

Magnetic Resonance Imaging of the Brain with and without Contrast

Undergo brain MRI

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jeremey Brownstein, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-06

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations