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NCT05616624 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Washington University School of Medicine.

Active
Registry status
Phase 1
Development phase
31
Enrollment target
3
Study locations

NCT05616624 is a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 31 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05616624, a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
31 participants
Enrollment target
3
Study locations

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.

Conditions Studied

Non-Small Cell Lung Cancer Small-cell Lung Cancer Small Cell Lung Carcinoma

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

Sponsor

Washington University School of Medicine

1,502 total trials

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What the Registry Record Tells You About NCT05616624

The ClinicalTrials.gov registry entry for NCT05616624 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.

NCT05616624 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Missouri, Virginia.

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, Small-cell Lung Cancer, Small Cell Lung Carcinoma.

What interventions are being tested in trial NCT05616624?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), ADI-PEG 20 (DRUG).

Who is sponsoring clinical trial NCT05616624?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.