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ACTIVE NOT RECRUITING Phase 1

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

NCT05616624 · View on ClinicalTrials.gov ↗

Study 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 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.

Interventions

  • DRUG Docetaxel
  • DRUG Gemcitabine
  • DRUG ADI-PEG 20

Study Locations (3)

Illinois

  • Northwestern University — Chicago

Missouri

  • Washington University School of Medicine — St Louis

Virginia

  • Inova Schar Cancer Institute — Fairfax

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2023-04-05
Est. Completion 2033-12-31
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05616624

The ClinicalTrials.gov registry entry for NCT05616624 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05616624 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Illinois, Missouri, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05616624 about?

NCT05616624 is a clinical study titled "ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers". 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 patient...

What is the current status of trial NCT05616624?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2023-04-05. Estimated completion is 2033-12-31.

What conditions does trial NCT05616624 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Small Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05616624?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), ADI-PEG 20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05616624?

This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05616624 being conducted?

This trial has 3 study locations across Illinois, Missouri, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial