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NCT04743505 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

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

Active
Registry status
Phase 1
Development phase
27
Enrollment target
1
Study location

NCT04743505 is a Phase 1 study of Metastatic Non Small Cell Lung Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 393-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04743505, a Phase 1 study of Metastatic Non 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
27 participants
Enrollment target
1
Study location

Study Summary

In this study, patients with metastatic non-small cell lung cancer that is EGFR-mutated, who have received at least 8 and not more than 12 weeks of treatment with osimertinib without demonstrating disease progression, will receive APL-101 in combination with osimertinib until progression. Dosing of APL-101 will be escalated until the maximum tolerated dose is determined, at which point 10 additional patients will be enrolled at that dose in the expansion cohort.

Interventions

  • DRUG Osimertinib
  • DRUG APL-101

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2022-01-18
Est. Completion 2029-12-31
Phase Phase 1

What the Registry Record Tells You About NCT04743505

The ClinicalTrials.gov registry entry for NCT04743505 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (93% 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 1 condition, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.

NCT04743505 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT04743505 about?

NCT04743505 is a clinical study titled "Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)". In this study, patients with metastatic non-small cell lung cancer that is EGFR-mutated, who have received at least 8 and not more than 12 weeks of treatment with osimertinib without demonstrating disease progression, will receive APL-101 in combination with osimertinib until progression. Dosing of ...

What is the current status of trial NCT04743505?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-01-18. Estimated completion is 2029-12-31.

What conditions does trial NCT04743505 study?

This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.

What interventions are being tested in trial NCT04743505?

The interventions under investigation include: Osimertinib (DRUG), APL-101 (DRUG).

Who is sponsoring clinical trial NCT04743505?

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

Where is trial NCT04743505 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.