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Non Small Cell Lung CancerPhase 1/2NCT05616624

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

A Phase 1/2 study testing ADI-PEG 20, Gemcitabine and Docetaxel in people with Non Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Washington University School of Medicine at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ADI-PEG 20, Gemcitabine and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
3 sitesUnited States
Study dates
5 Apr 2023to 22 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients with NSCLC without a driver mutation must have been treated with platinum doublet and anti-PD(L)1 therapy, if eligible.
  • Patients with NSCLC with a driver mutation (EGFR, ALK, ROS1) must have been treated with an FDA approved targeted therapy and platinum doublet therapy, if eligible.
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  • If the most recent prior line included immunotherapy, patient must have experienced progression by CT scan after cessation of immunotherapy and prior to starting study therapy.
  • Patient must have archival tissue available for correlatives. If tissue is not available, approval of enrollment may be granted on a case-by-case basis. Sponsor-investigator approval is required in these instances.
  • At least 18 years of age.
  • ECOG performance status ≤ 1.
  • Adequate bone marrow and organ function as defined below:
  • Absolute neutrophil count ≥ 1.5 K/cumm
  • Platelets ≥ 100 K/cumm
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 x IULN, patients with Gilberts must be below 3xIULN
  • AST(SGOT)/ALT(SGPT) ≤ 3 x IULN (or ≤ 5 x IULN if liver metastases are present)
  • Creatinine clearance > 60 mL/min by MDRD or by 24 hour urine
  • Serum uric acid ≤ 8 mg/dL (with or without medication control)
  • If patient is on oxygen, must require 3L O2 at rest or less.
  • The effects of ADI-PEG 20 on the developing human fetus are unknown. For this reason and because chemotherapeutics are known to be teratogenic, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for one month after completion of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for one month after completion of study treatment.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Who cannot join

  • A history of other malignancy with the exception of:
  • Malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease
  • Basal cell or squamous cell carcinoma of the skin which was treated with local resection only
  • Carcinoma in situ of the cervix
  • Other tumors discussed with the study PI
  • Receipt of any of the following therapies within the below time frames:
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  • 21 days for chemotherapy
  • 21 days or 5 half-lives for an oral small molecule inhibitor (whichever is shorter)
  • 21 days for immunotherapy
  • 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).
  • Presence of untreated or unstable brain metastases. Patients with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry, are eligible.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, gemcitabine, pegylated compounds, or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • History of seizure disorder not related to underlying cancer.
  • Grade 2 or higher neuropathy
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Patients with known active Hepatitis B or C or HIV.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Although safety and tolerability has been previously determined in the sarcoma population, dose de-escalations of the chemotherapies in that patient population were required. Therefore, a phase I portion will be incorporated to determine the RP2D of the triplet in this population.

Being tested
ADI-PEG 20, Gemcitabine, Docetaxel
Keywords
Arginine Starvation, ADI-PEG20, SCLC, NSCLCa
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADI-PEG 20Drug

    Also called PEGylated arginine deiminase

    -Given 60 minutes (+/- 15 minutes) prior to docetaxel

  • GemcitabineDrug

    Also called Gemzar

    -Given over the course of 90 minutes (+/- 10 minutes)

  • DocetaxelDrug

    Also called Taxotere

    -Given over the course of 60 minutes (+/- 10 minutes)

Study groups in NCT05616624
Study groupRoleWhat they receive
Phase I: ADI-PEG + gemcitabine + docetaxelExperimental* 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.
Receives: Drug: ADI-PEG 20; Drug: Gemcitabine; Drug: Docetaxel
Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental* 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.
Receives: Drug: ADI-PEG 20; Drug: Gemcitabine; Drug: Docetaxel
Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental* 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.
Receives: Drug: ADI-PEG 20; Drug: Gemcitabine; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase II dose (Phase I only)

    -The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first 4 weeks of treatment. Dose escalations will proceed until the MTD has been reached or until Dose Level 3, and this dose level will then be defined as the Recommended Phase 2 Dose (RP2D).

    Measured: Through the first 4 weeks of treatment for all Phase I enrolled participants (estimated to be 12 months and 4 weeks)

  2. Treatment-related serious adverse event (SAE) rate (Phase I only)

    -SAE: an adverse event or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes:

    • Death
    • A life-threatening adverse event
    • Inpatient hospitalization or prolongation of existing hospitalization
    • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • A congenital anomaly/birth defect
    • Any other important medical event that does not fit the criteria above but, based upon appropriate medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above

    Measured: From start of treatment through 30 days after completion of treatment (estimated to be 106 weeks)

  3. Objective response rate (ORR) (Phase II only - compared between non-small cell lung and small cell lung)

    • ORR = percentage of participants with complete response, partial response, or stable disease for 8 cycles
    • Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
    • Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
    • Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Through completion of treatment (estimated to be 102 weeks)

Secondary outcomes (4)

  1. Progression-free survival (PFS) (Phase II only - compared between non-small cell lung and small cell lung)

    • PFS is defined as the time from date of treatment initiation to disease progression or death from any cause, whichever occurs first. The patients alive, without progression, are censored at the last follow-up.
    • Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: Through completion of follow-up (estimated to be up to 362 weeks)

  2. Overall survival (OS) (Phase II only - compared between non-small cell lung and small cell lung)

    OS is defined as the time from the date of treatment initiation to the date of death, censored at the last follow-up otherwise.

    Measured: Through completion of follow-up (estimated to be up to 362 weeks)

  3. Clinical benefit rate (CBR) (Phase II only - compared between non-small cell lung and small cell lung)

    • CBR = the percentage of participants who have experienced complete response + partial response + stable disease.
    • Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
    • Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
    • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

    Measured: Through completion of treatment (estimated to be 102 weeks)

  4. Cancer-related mortality rate (Phase II only - compared between non-small cell lung and small cell lung)

    Measured: Through completion of follow-up (estimated to be up to 362 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2022
  2. Study start5 Apr 2023
  3. Primary completion22 Jul 2026
  4. Study completion22 Jul 2026

Why it stopped: Polaris has decided to close to accrual due to low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616624
Sponsor's protocol ID
202301032
Status last verified
Jul 2026
First submitted
4 Nov 2022
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ADI-PEG 20, Gemcitabine and Docetaxel in people with Non Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Washington University School of Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Polaris has decided to close to accrual due to low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (Phase I only) (time frame: Through the first 4 weeks of treatment for all Phase I enrolled participants (estimated to be 12 months and 4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05616624.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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