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Kinase Inhibitor

Aurora A Kinase Inhibitor + Osimertinib for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Xiuning Le

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed non-squamous, non-small cell lung cancer locally advanced or metastatic disease.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last dose

Awards & highlights

Study Summary

This trial is testing a drug combination to see if it's effective in treating patients with a certain type of lung cancer.

Who is the study for?

This trial is for adults with advanced or metastatic non-squamous, EGFR-mutant non-small cell lung cancer who have progressed on osimertinib or similar treatments. They must be able to swallow pills, have measurable disease, and good organ function. Prior chemotherapy or immunotherapy is okay. Women of childbearing age and sexually active men must use contraception.Check my eligibility

What is being tested?

The trial tests the combination of LY3295668 (an aurora A kinase inhibitor) with osimertinib to see if they can better control tumor growth in patients by blocking enzymes needed for cell growth. It's a phase Ib/II study that also looks at side effects and the best dose.See study design

What are the potential side effects?

Potential side effects include issues related to enzyme inhibition affecting cell growth which may lead to abnormal blood counts, digestive disturbances, fatigue, possible heart rhythm problems (QTc prolongation), and other common drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced or has spread, and it's not the squamous type.

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I am able to get out of my bed or chair and move around.

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My NSCLC has a specific EGFR mutation.

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I am 18 years old or older.

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I have a tumor larger than 10mm that hasn't been treated with radiation.

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I can swallow pills or capsules.

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I am a man who can father children and will use birth control.

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My blood, liver, and kidney tests are within normal ranges.

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I am not pregnant and agree to use birth control.

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I have been treated with a specific lung cancer medication and my cancer has progressed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity and recommended phase 2 dose

Secondary outcome measures

Best objective response rate

Overall survival

Progression-free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (osimertinib, aurora A kinase inhibitor LY3295668)Experimental Treatment2 Interventions

Patients receive osimertinib PO QD and aurora A kinase inhibitor LY3295668 PO BID on days 1-28. Treatment repeats every 28 days for 24 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1010

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,205 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,455 Total Patients Enrolled

Xiuning LePrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

174 Total Patients Enrolled

Media Library

Aurora A Kinase Inhibitor LY3295668 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05017025 — Phase 1 & 2

Lung Carcinoma Research Study Groups: Treatment (osimertinib, aurora A kinase inhibitor LY3295668)

Lung Carcinoma Clinical Trial 2023: Aurora A Kinase Inhibitor LY3295668 Highlights & Side Effects. Trial Name: NCT05017025 — Phase 1 & 2

Aurora A Kinase Inhibitor LY3295668 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017025 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a groundbreaking study in its field?

"Since 2013, Aurora A Kinase Inhibitor LY3295668 has been the subject of extensive research. After a Phase 1 & 2 clinical trial sponsored by AstraZeneca in 2013 involving 603 patients, it received drug approval and is now being studied at 101 different sites spanning 51 countries across 1059 cities."

Answered by AI

What is the size of the cohort being observed in this clinical research?

"Affirmative. The evidence available on clinicaltrials.gov bolsters the notion that this research is actively recruiting individuals; having been initially posted on February 17th 2022 and most recently updated June 29th 2022, with 30 participants sought across one site."

Answered by AI

Are there any prior studies that have incorporated Aurora A Kinase Inhibitor LY3295668?

"Currently, 101 clinical trials for Aurora A Kinase Inhibitor LY3295668 are ongoing with 17 in the third phase. While many of these experiments take place at Uniondale, New york, a grand total of 4702 sites across the world host such studies."

Answered by AI

Are there any currently open opportunities for enrolment in this research?

"Affirmative, clinicaltrials.gov reveals that this research is still enrolling participants. The experiment was initially made public on February 17th 2022 and had its most recent edits done June 29th of the same year. 30 patients are being sought across one centre for participation in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer

2022. "Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05017025.