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Alkylating agents

Vitamin C with Chemotherapy and Radiation for Lung Cancer (XACT-LUNG Trial)

Phase 2
Recruiting
Research Sponsored by Joseph J. Cullen, MD, FACS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Pathologic diagnosis of non-small cell lung cancer
Must not have
Patients who are on the following drugs and cannot have a substitution or who decline the substitution: warfarin, flecainide, methadone, amphetamines, quinidine, chlorpropamide
Exudative pleural effusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every six months for up to 20 years post-treatment
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing whether adding high doses of vitamin C to standard radiation and chemotherapy treatment for lung cancer improves outcomes.

Who is the study for?
This trial is for adults with non-small cell lung cancer who are healthy enough for chemotherapy and radiation, have a measurable tumor of at least 1 cm by CT or MRI, and not pregnant. They must have normal platelet counts and kidney function, no severe pleural effusion, no G6PD deficiency, not on certain medications like warfarin or insulin, and not HIV positive on antiretroviral therapy.
What is being tested?
The study tests adding high-dose vitamin C (ascorbate) to the standard treatment regimen of carboplatin and paclitaxel chemotherapy combined with radiation therapy. All participants will receive this additional ascorbate alongside their prescribed treatments.
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss; radiation therapy like skin irritation; plus any unique reactions to high doses of vitamin C which could range from digestive discomfort to possible interference with blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function tests are within the required range.
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I have been diagnosed with non-small cell lung cancer.
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My lung cancer can be seen and measured on a scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking one of the specified drugs and cannot or will not switch to a different one.
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I have fluid buildup in the lining of my lungs.
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I have G6PD deficiency.
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I have had radiation therapy in the same area before.
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I do not have any uncontrolled illnesses.
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I am HIV positive and on treatment that might interact with high-dose vitamin C.
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My lung cancer has come back after treatment.
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I am currently using insulin as recommended by my doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every six months for up to 20 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and every six months for up to 20 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression rate at completion of radiation and chemotherapy
Secondary study objectives
Adverse event frequency and categorization
Overall survival (OS)
Progression free survival (PFS)
+1 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ChemoRT + AscorbateExperimental Treatment4 Interventions
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Carboplatin
FDA approved
Ascorbic acid
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,077 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,071 Total Patients Enrolled
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
721 Total Patients Enrolled
Joseph J. Cullen, MD, FACSLead Sponsor
3 Previous Clinical Trials
128 Total Patients Enrolled
Joseph J Cullen, MD, FACSStudy DirectorUniversity of Iowa
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02905591 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: ChemoRT + Ascorbate
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02905591 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02905591 — Phase 2
~6 spots leftby Dec 2025
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