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Checkpoint Inhibitor

Vitamin C + Durvalumab for Lung Cancer

Phase 1

Recruiting

Led By Muhammad Furqan, MD

Research Sponsored by Muhammad Furqan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to three years following completion of treatment

Awards & highlights

Study Summary

This trial tests if a drug made from Vitamin C can boost a cancer treatment to improve its effectiveness.

Who is the study for?

Adults over 18 with confirmed non-small cell lung cancer that's surgically removable and hasn't spread, who are in good health with proper organ function. They must expect to live at least 12 weeks, weigh over 30 kg, and have no history of severe allergies or other cancers. Women of childbearing age must use effective contraception.Check my eligibility

What is being tested?

The trial is testing the combination of a high-dose vitamin C (pharmacological ascorbate) with Durvalumab immunotherapy against standard surgery for early-stage lung cancer. It aims to see if this mix can better modulate the immune system to fight cancer.See study design

What are the potential side effects?

Durvalumab may cause immune-related reactions affecting various organs, fatigue, skin rash, or infections. High-dose vitamin C could lead to digestive discomfort or kidney stones. Surgery risks include bleeding, infection, and anesthesia complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer diagnosis was confirmed through lab tests.

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My breast cancer is early stage, with a tumor size between >1cm and 4cm, and it hasn't spread to lymph nodes or other parts of my body.

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My lung function is good enough for surgery, as confirmed by a thoracic surgeon.

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I am fully active or can carry out light work.

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My body weight is over 30 kg.

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My kidney function, measured by creatinine clearance, is good.

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I agree to use effective birth control during and 90 days after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to three years following completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to three years following completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to three years following completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CD8+ T cells quantified as the percentage of lymphocytes that are CD8+ T cells

Secondary outcome measures

Event-Free Survival

Incidence of dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5

Major Pathologic Response (MPR) rate

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Durvalumab as monotherapyExperimental Treatment1 Intervention

Two cycles of Durvalumab 1500 mg every 3 weeks, as monotherapy

Group II: Combination of pharmacological ascorbate plus DurvalumabExperimental Treatment2 Interventions

Combination of pharmacological ascorbate 75 grams intravenously three times a week x 4 weeks plus Durvalumab 1500 mg every 3 weeks for two cycles

Group III: Control (no neoadjuvant therapy)Active Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Muhammad FurqanLead Sponsor

4 Previous Clinical Trials

91 Total Patients Enrolled

Muhammad Furqan, MDPrincipal InvestigatorUniversity of Iowa

2 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can Durvalumab be administered solo and still provide advantageous outcomes?

"The safety score for Durvalumab as a single agent is 1 due to the limited information available that supports its efficacy and safety."

Answered by AI

Is there still availability for individuals to participate in this investigation?

"Per the information on clinicaltrials.gov, this medical investigation is not currently recruiting participants. Initially posted on November 1st 2023 and last updated October 10th 2023, it appears that this trial has temporarily ceased intake of volunteers despite there being 1996 other trials in search for patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Muhammad Furqan 2023. "Ascorbate With Durvalumab in Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083454.