TerminatedPhase 1NCT06083454
Official study title

Ascorbate With Durvalumab in Non-Small Cell Lung Cancer (NSCLC)

Study summary

This is a descriptive, proof of concept, open-label, randomized, 3-arm, window of opportunity trial to evaluate the immunomodulatory role of pharmacological ascorbate with Durvalumab

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab and Pharmacological ascorbate

Plus 1 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 Mar 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?William Zeitler

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
William Zeitler
Interventions being studied
Drug: Durvalumab; Drug: Pharmacological ascorbate; Procedure: Surgery (SOC)
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
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Age \> 18 years at time of study entry regardless of gender or ethnic/racial background.
  • Histologically or cytologically confirmed non-small cell lung cancer
  • Clinical stage I with tumor size \>1 cm to 4 cm (either T1b or T1c or T2a and N0 M0) according to American Joint Committee on Cancer 8th edition
  • Surgically resectable with adequate lung functions to undergo surgery as determined by thoracic surgeon.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Body weight \>30 kg
  • Adequate normal organ and marrow function as defined below:
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) ≥1.0 × 109 /L
  • Platelet count ≥75 × 109/L
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\>\>
  • AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal.
  • Measured creatinine clearance (CL) ≥50 mL/min or Calculated creatinine CL≥50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Males: Creatinine CL (mL/min)= Weight (kg) x (140 - Age) divided by 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min)= Weight (kg) x (140 - Age) x 0.85 divided by 72 x serum creatinine (mg/dL)
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Must have a life expectancy of at least 12 weeks
  • Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from the time of screening, throughout the total duration of the drug treatment, and during the 90-day post-drug washout period.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women 1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Reasons someone may not be able to joinExclusion criteria

Patients should not enter the study if any of the following

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

  • University of IowaIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2026. Always confirm current availability with the study team.

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