Active Not RecruitingPhase 2NCT02905591
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRadiation Therapy and Paclitaxel

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 31, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Joseph J. Cullen, MD, FACS

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Joseph J. Cullen, MD, FACS
Interventions being studied
Drug: Radiation Therapy; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ascorbic Acid
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Holden Comprehensive Cancer CenerIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2026. Always confirm current availability with the study team.

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