Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced o… (NCT05017025) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer
United States32 participantsStarted 2022-02-17
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of aurora A kinase inhibitor LY3295668 when given together with osimertinib in patients with EGFR-mutant non-squamous non-small cell lung cancer that has spread to other places in the body (advanced or metastatic). Aurora A kinase inhibitor LY3295668 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving aurora A kinase inhibitor LY3295668 in combination with osimertinib may help control EGFR-mutant non-squamous non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent.
✓. Age ≥ 18 years at the time of consent.
✓. Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
✓. Locally advanced or metastatic disease.
✓. Patients must have one of the following:
✓. The patient must have received a third-generation EGFR TKI treatment, regardless of the T790M status. The patient must have progressed on osimertinib, or an equivalent third-generation EGFR TKI with regulatory approval.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix A)
✓. At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline at equal or greater than 10mm in the longest dimension by RECIST 1.1.
Exclusion criteria
What they're measuring
1
Dose-limiting toxicity and recommended phase 2 dose
✕. Previous treatment with other aurora kinase inhibitors.
✕. Spinal cord compression or brain metastases unless asymptomatic or stable for at least 2 weeks prior to start of study treatment.
✕. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia grade 2) at the time of starting study treatment.
✕. Any evidence of severe or uncontrolled systemic diseases. Screening for chronic conditions is not required.
✕. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
✕. Males and females of reproductive potential who are not using and effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
✕. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement.