Suspended

ADI-PEG 20, Gemcitabine, and Docetaxel for Lung Cancer After Frontline Therapy Progression

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Study Aim

This study aims to evaluate the safety, optimal dosing, and effectiveness of the combination of ADI-PEG 20, Gemcitabine, and Docetaxel in patients with lung cancer who have experienced progression after initial treatment.

What is being tested

ADI-PEG 20

+ Gemcitabine

+ Docetaxel

Drug
Who is being recruted

Bronchial Neoplasms+8

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+41 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: April 2023
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 5, 2023

Actual date on which the first participant was enrolled.

This study is designed for patients with small cell or non-small cell lung cancer who have shown progression after initial treatment. The goal is to evaluate the effectiveness and safety of a combination of three drugs: ADI-PEG 20, gemcitabine, and docetaxel. This research is important because finding a new effective treatment can significantly improve care for those whose cancer has progressed despite receiving first-line therapy. By identifying the optimal dose, this study aims to enhance treatment options for these patients. Participants will receive the drugs ADI-PEG 20, gemcitabine, and docetaxel, with the method of administration not specified but typically involving intravenous infusions. Initially, the study tests different doses to determine the most suitable one that patients can tolerate well. Once the best dose is found, more patients will receive this dose to assess how well it works in reducing cancer. Researchers will measure the treatment's success by the percentage of patients whose tumors shrink or disappear. They will also monitor any serious side effects that could occur, such as severe health issues requiring hospitalization. The focus is on ensuring that the benefits outweigh any potential risks.

Official TitleADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
NCT05616624
Principal SponsorWashington University School of Medicine
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

Criteria

21 inclusion criteria required to participate
Histologically or cytologically confirmed extensive stage small cell or metastatic non-small cell lung cancer that has progressed on frontline therapy who are fit for treatment with gemcitabine and docetaxel in the opinion of the treating physician. Phase II enrollment will occur separately to the SCLC and NSCLC cohorts, with up to 36 enrolled in each cohort.
Measurable disease per RECIST 1.1.
Treated with at least one previous line of systemic therapy. Specific prior treatment requirements include:
Patients with ES-SCLC must have been treated with platinum doublet and anti-PD(L)1 therapy, if eligible.
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20 exclusion criteria prevent from participating
21 days for RT, or 7 days for SBRT or any palliative radiation
21 days for surgery
28 days for an investigational agent.
Prior treatment with ADI-PEG 20 or gemcitabine (prior docetaxel is allowed).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
* 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

Experimental
* 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

Experimental
* 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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Northwestern University

Chicago, United StatesOpen Northwestern University in Google Maps
Suspended

Washington University School of Medicine

St Louis, United States
Suspended

Inova Schar Cancer Institute

Fairfax, United States
Suspended3 Study Centers