A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.

Official Title
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Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: LY3295668 Erbumine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage. Have adequate organ function. Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. Have discontinued previous treatments for cancer. Are able to swallow capsules. Exclusion Criteria: Currently enrolled in a clinical study. Have a serious concomitant systemic disorder. Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C. Have a significant cardiac condition. Have previously received an aurora kinase inhibitor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3295668 Erbumine Cohort A<br>LY3295668 erbumine administered orally. | Drug: LY3295668 Erbumine<br>* oral capsules<br>|
| Experimental: LY3295668 Erbumine Cohort B<br>LY3295668 erbumine administered orally. | Drug: LY3295668 Erbumine<br>* oral capsules<br>|
| Experimental: LY3295668 Part JP<br>LY3295668 erbumine administered orally. | Drug: LY3295668 Erbumine<br>* oral capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Dose Reductions | Number of Participants with Dose Reductions | Baseline through Cycle 1 (28 Day Cycle) | 
| Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | ORR: Percentage of participants who achieve CR or PR | Baseline through Measured Progressive Disease (Estimated up to 20 Months) | 
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine | PK: AUC of LY3295668 Erbumine | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | 
| Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Maximum Concentration (Cmax) of LY3295668 Erbumine | PK: Cmax of LY3295668 Erbumine | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | 
| Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) | BOR | Baseline to Date of Objective Disease Progression (Estimated up to 20 Months) | 
| Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD | DCR | Baseline through Measured Progressive Disease (Estimated up to 20 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA