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Enzyme Depletion

ADI-PEG 20 + Chemotherapy for Lung Cancer

Phase 1 & 2

Recruiting

Led By Brian A Van Tine, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Normal bone marrow and organ function as defined

Patients with NSCLC with a driver mutation (EGFR, ALK, ROS1) must have been treated with an FDA approved targeted therapy and subsequent platinum doublet therapy, if eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)

Awards & highlights

Study Summary

This trial tests a 3-drug combo to treat lung cancer that has progressed on frontline treatment; first, a phase I will test different doses, then phase II will use the recommended dose to assess efficacy.

Who is the study for?

Adults with small cell or non-small cell lung cancer that's worsened after initial treatment can join. They must have tried specific therapies based on their cancer type, be in good physical condition, and not be pregnant or breastfeeding. People with certain other cancers, active infections like Hepatitis B/C or HIV, severe neuropathy, untreated brain metastases, serious heart conditions, or a history of seizures unrelated to cancer are excluded.Check my eligibility

What is being tested?

The trial is testing ADI-PEG 20 combined with chemotherapy drugs Gemcitabine and Docetaxel in patients whose lung cancer has progressed despite first-line therapy. The study starts by finding the safest dose combination (Phase I) before moving on to see how well it works at that dose (Phase II).See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system's response to ADI-PEG 20 and typical chemotherapy-related issues such as fatigue, nausea, hair loss, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My bone marrow and organs are functioning normally.

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I have NSCLC with a specific mutation and have been treated with targeted and platinum-based therapies.

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My lung cancer has worsened after initial treatment and I am considered fit for gemcitabine and docetaxel therapy.

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My NSCLC lacks a driver mutation and I've had first-line therapy with platinum and anti-PD(L)1, if I was eligible.

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I have had at least one treatment for my condition before.

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I am fully active and can carry on all pre-disease activities without restriction.

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I have small cell lung cancer and received initial treatment with platinum and anti-PD(L)1 therapy.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Non-Small Cell Lung Carcinoma

Recommended phase II dose (Phase I only)

Therapeutic procedure

Secondary outcome measures

Non-Small Cell Lung Carcinoma

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental Treatment3 Interventions

ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1. Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle. Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle. A cycle is defined as 21 days. After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request. Treatment may continue for up to 34 cycles.

Group II: Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental Treatment3 Interventions

Group III: Phase I: ADI-PEG + gemcitabine + docetaxelExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADI-PEG 20

2013

Completed Phase 2

~190

Gemcitabine

2017

Completed Phase 3

~2070

Docetaxel

1995

Completed Phase 4

~5620

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,601 Total Patients Enrolled

Polaris GroupIndustry Sponsor

24 Previous Clinical Trials

3,179 Total Patients Enrolled

Brian A Van Tine, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

238 Total Patients Enrolled

Media Library

ADI-PEG 20 (Enzyme Depletion) Clinical Trial Eligibility Overview. Trial Name: NCT05616624 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Phase I: ADI-PEG + gemcitabine + docetaxel, Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel, Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel

Non-Small Cell Lung Cancer Clinical Trial 2023: ADI-PEG 20 Highlights & Side Effects. Trial Name: NCT05616624 — Phase 1 & 2

ADI-PEG 20 (Enzyme Depletion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616624 — Phase 1 & 2

Frequently Asked Questions

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

Are patients currently being signed up for this clinical trial?

"The clinical trial in question is no longer recruiting patients, as indicated by its last update on November 14th, 2022. However, out of the 2210 other trials seeking participants, this one was initially posted most recently on January 31st, 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers

2023. "ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05616624.

All > Small Cell Lung Cancer > Sclc