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NCT05166616 · ClinicalTrials.gov registry record · Phase 1

Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer

A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by City of Hope Medical Center.

Active
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT05166616 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8 that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 8 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05166616, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by City of Hope Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

This phase Ib trial tests the side effects and best dose of minnelide when given together with osimertinib for the treatment of non-small cell lung cancer that has spread to other places in the body (advanced) and has a change (mutation) in a gene called EGFR. Minnelide is a biologically inactive compound that can be broken down in the body to produce a drug that rapidly releases the active compound triptolide when exposed to phosphatases in the bloodstream. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Minnelide and osimertinib may work better in treating patients with EGFR mutant advanced non-small cell lung cancer.

Conditions Studied

Stage IV Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Advanced Lung Non-Small Cell Carcinoma Locally Advanced Lung Non-Small Cell Carcinoma Unresectable Lung Non-Small Cell Carcinoma

Interventions

  • PROCEDURE Biopsy
  • DRUG Osimertinib
  • DRUG Triptolide Analog

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2022-03-07
Est. Completion 2027-10-28
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05166616

The ClinicalTrials.gov registry entry for NCT05166616 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (92% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Biopsy is the first listed.

NCT05166616 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05166616 about?

NCT05166616 is a clinical study titled "Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer". This phase Ib trial tests the side effects and best dose of minnelide when given together with osimertinib for the treatment of non-small cell lung cancer that has spread to other places in the body (advanced) and has a change (mutation) in a gene called EGFR. Minnelide is a biologically inactive co...

What is the current status of trial NCT05166616?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-03-07. Estimated completion is 2027-10-28.

What conditions does trial NCT05166616 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8.

What interventions are being tested in trial NCT05166616?

The interventions under investigation include: Biopsy (PROCEDURE), Osimertinib (DRUG), Triptolide Analog (DRUG).

Who is sponsoring clinical trial NCT05166616?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05166616 being conducted?

This trial has 1 study location across California. 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.