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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
Must not have
Patients with known active Hepatitis B or C or HIV
Grade 2 or higher neuropathy
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
No Placebo-Only Group
Summary
This trial tests a combination of three drugs to treat lung cancer patients who did not respond to initial treatments. The drugs work by starving the cancer cells and attacking them with chemotherapy.
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.
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).
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 belowSelect...
My bone marrow and organs are functioning normally.
Select...
I have NSCLC with a specific mutation and have been treated with targeted and platinum-based therapies.
Select...
My NSCLC lacks a driver mutation and I've had first-line therapy with platinum and anti-PD(L)1, if I was eligible.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active Hepatitis B, C, or HIV.
Select...
I have moderate to severe nerve damage.
Select...
I have previously been treated with ADI-PEG 20 or gemcitabine.
Select...
I have brain metastases that haven't been treated or are unstable.
Select...
I do not have any uncontrolled illnesses or heart problems.
Select...
I have a history of seizures not caused by my cancer.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Non-Small Cell Lung Carcinoma
Recommended phase II dose (Phase I only)
Therapeutic procedure
Secondary study objectives
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
* 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 III: Phase I: 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.
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
~1920
Docetaxel
1995
Completed Phase 4
~6550
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy drugs like gemcitabine and docetaxel work by interfering with the DNA replication process, thereby inhibiting cancer cell growth and inducing cell death.
Immunotherapy, such as PD-1/PD-L1 inhibitors (e.g., nivolumab, pembrolizumab), enhances the immune system's ability to recognize and destroy cancer cells. Targeted therapies, including EGFR and ALK inhibitors, specifically target genetic mutations driving cancer growth.
ADI-PEG 20, an arginine-depleting enzyme, starves cancer cells of arginine, an amino acid essential for their growth. Understanding these mechanisms is crucial for NSCLC patients as it helps tailor treatments to their specific cancer type, potentially improving efficacy and reducing side effects.
A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.
A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,988 Previous Clinical Trials
2,294,720 Total Patients Enrolled
Polaris GroupIndustry Sponsor
24 Previous Clinical Trials
3,247 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow and organs are functioning normally.You have had allergic reactions to certain substances in the past.My lung cancer has worsened after initial treatment and I am considered fit for gemcitabine and docetaxel therapy.My NSCLC lacks a driver mutation and I've had first-line therapy with platinum and anti-PD(L)1, if I was eligible.I have NSCLC with a specific mutation and have been treated with targeted and platinum-based therapies.I have had at least one treatment for my condition before.I am fully active and can carry on all pre-disease activities without restriction.I have small cell lung cancer and received initial treatment with platinum and anti-PD(L)1 therapy.I have active Hepatitis B, C, or HIV.I am 18 years old or older.You have had cancer before, except in certain cases.I have moderate to severe nerve damage.I have previously been treated with ADI-PEG 20 or gemcitabine.I have brain metastases that haven't been treated or are unstable.I do not have any uncontrolled illnesses or heart problems.I have a history of seizures not caused by my cancer.You have a disease that can be measured using a specific standard.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: ADI-PEG + gemcitabine + docetaxel
- Group 2: Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
- Group 3: Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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