A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

Running, not enrolling · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, NSCLC

In brief

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.

Key facts

Study ID

NCT02905591

Run by

Joseph J. Cullen, MD, FACS

People needed

43

Starts

2018-11-16

Expected to finish

2027-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible
• Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer.
• Recommended to receive carboplatin \& paclitaxel with radiation therapy as a treatment
• Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan)
• Physician determined the patient is healthy enough for chemotherapy and radiation therapy
• At least part of the lung cancer must be viewable and measurable by CT or MRI
• A platelet count of at least 100,000 cells per mililiter
• A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min*1.73m2)
• Not pregnant, and commit to using birth control during the study

You may not qualify if…

• Exudative pleural effusion
• Recurrent non-small cell lung cancer
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Patients actively receiving insulin or patients whose doctors have recommended current insulin use
• Patients requiring daily finger-stick blood glucose measurements
• Patients who are on the following drugs and cannot have a substitution or who decline the substitution:
• warfarin
• flecainide
• methadone
• amphetamines
• quinidine
• chlorpropamide
• Prior radiation therapy that would result in a field overlap
• Enrolled in another therapeutic clinical trial
• Uncontrolled, intercurrent illness
• Lactating women
• HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy
• If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.

Where it is running

• Holden Comprehensive Cancer Cener — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.