NCT02905591Active, not recruitingPhase 2
A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC
A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 14 Sept 2016
- Start date
- 16 Nov 2018
- Primary completion date
- 15 Jul 2025
- Lead sponsor
- Joseph J. Cullen, MD, FACS
- Diseases
- Lung cancer
- NCT number
- NCT02905591
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 16 Nov 2018 to the primary completion date, 15 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients actively receiving insulin or patients whose doctors have recommended current insulin use
- 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
Other illness
- Recurrent non-small cell lung cancer
- Uncontrolled, intercurrent illness
- 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.
Lab values
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Patients requiring daily finger-stick blood glucose measurements
Other
- Exudative pleural effusion
- Enrolled in another therapeutic clinical trial
- Lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Holden Comprehensive Cancer Cener Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.