Carcinoma, Non-Small-Cell LungPhase 2XACT-LUNGNCT02905591
A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC
A Phase 2 study testing Radiation Therapy, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung and Non-Small Cell Lung Cancer, run by Joseph J. Cullen, MD, FACS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer
- What is being tested?
- Radiation Therapy, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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:
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Cener
Iowa City, Iowa, 52242
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, NSCLC
- Being tested
- Radiation Therapy, Paclitaxel, Carboplatin, Ascorbic Acid
- Keywords
- pharmacological ascorbate, ascorbic acid, radiation, chemotherapy, carboplatin, paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyDrug
Also called external beam radiation therapy (EBRT), intensity modulated radiation therapy (IMRT), Volumetric Arc Therapy (VMAT), XRT
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
PaclitaxelDrug
Also called Nov-Onxol, Onxol, Paclitaxel Novaplus, Taxol
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
CarboplatinDrug
Also called NovaPlus CARBOplatin, Amerinet Choice Carboplatin, Paraplatin, Paraplatin NovaPlus
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
Ascorbic AcidDrug
Also called Ascorbate, Vitamin C, Pharmacological ascorbate
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
| Study group | Role | What they receive |
|---|---|---|
| ChemoRT + Ascorbate | Experimental | Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate) Receives: Drug: Radiation Therapy; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Rate at the Completion of Radiation and Chemotherapy
The proportion of participants with progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the completion of radiation and chemotherapy.
Measured: 3 to 4 weeks after last radiation treatment
Secondary outcomes (4)
Tumor Response
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.
Measured: Every six months for up to 20 years post-treatment
Progression Free Survival (PFS)
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
Measured: Every six months for up to 20 years post-treatment
Overall Survival (OS)
Time, measured in months, from start of radiation to death from any cause.
Measured: Every three months for up to 20 years post-treatment
Adverse Event Frequency and Categorization
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
Measured: Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start16 Nov 2018
- Primary completion15 Jul 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph J. Cullen, MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Holden Comprehensive Cancer Center
- Responsible party
- Principal investigator, Bryan Allen, University of Iowa
- Investigators
- Joseph J Cullen, MD, FACS, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905591
- Sponsor's protocol ID
- 201712770
- Other IDs
- 3P30CA086862, 5U01CA140206, 1P01CA217797-01A1
- Acronym
- XACT-LUNG
- Status last verified
- Jul 2026
- First submitted
- 14 Sep 2016
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon request in compliance with the IRB application and protocol.
Publications
Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
PubMed 28366679
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02905591
- Acronym / sponsor ID
- XACT-LUNG / 201712770
- Conditions
- Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, NSCLC
- Keywords
- pharmacological ascorbate, ascorbic acid, radiation, chemotherapy, carboplatin, paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Joseph J. Cullen, MD, FACSUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Holden Comprehensive Cancer Center
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChemoRT + Ascorbate | Experimental | Drug: Radiation Therapy, Drug: Paclitaxel, Drug: Carboplatin, Drug: Ascorbic AcidRadiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyAlso: external beam radiation therapy (EBRT), intensity modulated radiation therapy (IMRT), Volumetric Arc Therapy (VMAT), XRTConformal 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 | Drug | ChemoRT + Ascorbate |
| PaclitaxelAlso: Nov-Onxol, Onxol, Paclitaxel Novaplus, TaxolAdministered 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 | Drug | ChemoRT + Ascorbate |
| CarboplatinAlso: NovaPlus CARBOplatin, Amerinet Choice Carboplatin, Paraplatin, Paraplatin NovaPlusAdministered 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 | Drug | ChemoRT + Ascorbate |
| Ascorbic AcidAlso: Ascorbate, Vitamin C, Pharmacological ascorbateAdministered 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 | Drug | ChemoRT + Ascorbate |
Primary outcome
Progression Rate at the Completion of Radiation and Chemotherapy
Time frame: 3 to 4 weeks after last radiation treatment
The proportion of participants with progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the completion of radiation and chemotherapy.
4 secondary outcomes
Tumor Response
Time frame: 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
Overall Survival (OS)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28366679Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon request in compliance with the IRB application and protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J Cullen, MD, FACS study director
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung and Non-Small Cell Lung Cancer, run by Joseph J. Cullen, MD, FACS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Rate at the Completion of Radiation and Chemotherapy (time frame: 3 to 4 weeks after last radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.