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

Eli Lilly and Company48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

LY3295668 ErbumineDRUG

oral capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (40)

Outcomes

Primary Outcomes

Number of Participants with Dose Reductions

Time frame: 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

Time frame: 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

Time frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

Duration of Response (DoR)

DoR

Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)

Secondary Outcomes

PK: Maximum Concentration (Cmax) of LY3295668 Erbumine

PK: Cmax of LY3295668 Erbumine

Time frame: 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

Time frame: 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

Time frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months)

Data from ClinicalTrials.gov

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