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

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 years

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, LY3295668 and osimertinib, in patients with advanced lung cancer that has a specific mutation and has spread. The drugs work by blocking enzymes and mutations that help cancer cells grow. Osimertinib is a third-generation treatment approved for advanced non-small cell lung cancer with specific mutations.

Research Team

Xiuning Le, M.D., Ph.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

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

My NSCLC has a specific EGFR mutation.

Exclusion Criteria

I have been treated with aurora kinase inhibitors before.

I do not have any severe or uncontrolled illnesses.

My heart's electrical activity is normal and I don't have factors increasing my risk of irregular heartbeat.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive osimertinib orally once daily and aurora A kinase inhibitor LY3295668 orally twice daily on days 1-28, repeated every 28 days for 24 cycles (2 years) in the absence of disease progression or unacceptable toxicity

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days

1 visit (in-person) at 30 days, then every 4 months

Treatment Details

Interventions

• Aurora A Kinase Inhibitor LY3295668
• Osimertinib

Trial Overview 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.

Participant Groups

Group I: Treatment (osimertinib, aurora A kinase inhibitor LY3295668) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+