A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC (XACT-LUNG)

March 24, 2026 updated by: Bryan Allen, Joseph J. Cullen, MD, FACS

A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

For selected stages of non-small cell lung cancer (NSCLC), standard treatment involves radiation therapy and chemotherapy. The chemotherapy regimen typically used is paclitaxel and carboplatin. Both of these chemotherapeutic drugs are administered intravenously, using a vein in the arm. Radiation is administered using a machine external to the body (usually a linear accelerator). After combined therapy, NSCLC patients receive 2 extra cycles of chemotherapy, called "consolidation chemotherapy."

This study adds 75 grams of ascorbate (vitamin C, sometimes called pharmacological ascorbate because the dose is so high) at specific timepoints in the therapy. The ascorbate is administered intravenously - through a vein in your arm.

Participants will:

  • receive 75 grams of intravenous ascorbate 3 times per calendar week while they are receiving radiation therapy. The IV will be running while the radiation therapy is administered.
  • undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays.
  • provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy

This active therapy portion lasts for about 10 to 12 weeks. After that is done, participants go back to standard follow-up for their cancer and any additional therapy their doctors believe they need.

However, it is very important the investigators remain in contact with participants; they will have life-long follow-up for this study.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Cener

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Drug: Radiation Therapy
Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
Other Names:
  • XRT
  • external beam radiation therapy (EBRT)
  • intensity modulated radiation therapy (IMRT)
  • Volumetric Arc Therapy (VMAT)
Drug: Paclitaxel

Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered

  • the dose is 45 mg/m2 (standard dose)
  • Administered weekly
  • 6 to 7 weeks of therapy, depending on when radiation starts
  • Standardized dose reductions are used
Other Names:
  • Taxol
  • Nov-Onxol
  • Onxol
  • Paclitaxel Novaplus
Drug: Carboplatin

Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.

  • Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
  • Administered weekly
  • 6 to 7 weeks of therapy, depending on when radiation starts
  • Standard dose reductions are used
Other Names:
  • Paraplatin
  • NovaPlus CARBOplatin
  • Amerinet Choice Carboplatin
  • Paraplatin NovaPlus
Drug: Ascorbic Acid

Administered intravenously

  • 75 grams per infusion; each infusion is about 2 hours
  • 3 infusion per calendar week
  • The infusion is actively running for at least 20 minutes when radiation begins
  • May be given while chemotherapy is delayed due to low counts
  • Dose reductions are not used
  • Given for 6 to 7 weeks, depending on when radiation starts
Other Names:
  • Vitamin C
  • Ascorbate
  • Pharmacological ascorbate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression rate at completion of radiation and chemotherapy
Time Frame: 3 to 4 weeks after last radiation treatment
Tumor measurement from CT scan, using the RECIST criteria to define progression
3 to 4 weeks after last radiation treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: Every six months for up to 20 years post-treatment
From radiation day 1 to documented disease progression as described by RECIST criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
Every six months for up to 20 years post-treatment
Progression free survival (PFS)
Time Frame: Every six months for up to 20 years post-treatment
Time, measured in days, it takes for disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression
Every six months for up to 20 years post-treatment
Overall survival (OS)
Time Frame: Every three months for up to 20 years post-treatment
Time, measured in months, from start of radiation to death from any cause.
Every three months for up to 20 years post-treatment
Adverse event frequency and categorization
Time Frame: Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment

Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows:

  • Through radiation, weekly assessment of adverse events
  • Consolidation chemotherapy, assessment day 1 of each cycle
  • Post-treatment, every 6 months through 2 years post-therapy
Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph J. Cullen, MD, FACS

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center

Investigators

  • Study Director: Joseph J Cullen, MD, FACS, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2018

Primary Completion (Actual)

July 15, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimated)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201712770
  • 3P30CA086862 (U.S. NIH Grant/Contract)
  • 5U01CA140206 (U.S. NIH Grant/Contract)
  • 1P01CA217797-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared upon request in compliance with the IRB application and protocol.

IPD Sharing Time Frame

Upon request.

IPD Sharing Access Criteria

Contact the investigator or sub-investigator to initiate a request. A contract may be required between institutions. Data will be shared only from those participants who consented to sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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