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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
William Zeitler
Study ID
NCT06083454
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Given intravenous (IV) infusion as monotherapy or in combination with pharmacological ascorbate
  • Pharmacological ascorbate — DRUG
    Given intravenously in combination with Durvalumab
  • Surgery (SOC) — PROCEDURE
    Surgery SOC

Study Details

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

Key Dates

Start date
Oct 23, 2023
Status verified
Mar 2026
Primary completion
Apr 4, 2025
Completion
Jan 9, 2026

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab as monotherapy
    Two cycles of Durvalumab 1500 mg every 3 weeks, as monotherapy
  • Experimental: Combination of pharmacological ascorbate plus Durvalumab
    Combination of pharmacological ascorbate 75 grams intravenously three times a week x 4 weeks plus Durvalumab 1500 mg every 3 weeks for two cycles
  • Active Comparator: Control (no neoadjuvant therapy)
    Serve as control and patients will not receive any neoadjuvant therapy before going to surgery. Once randomize, they can go to surgery without any delays.

Primary Outcome Measure

CD8+ T cells quantified as the percentage of lymphocytes that are CD8+ T cells [ Time Frame: Following surgical resection which will be performed during weeks 5-9 from the day of randomization. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-

Find similar trials in Iowa City, IA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Iowa· Iowa City, IA

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