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

• ClinicalTrials.gov Identifier: NCT03898791
• Recruitment Status: Completed
• First Posted: April 2, 2019
• Last Update Posted: August 5, 2021
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: April 1, 2019
• First Posted Date: April 2, 2019
• Last Update Posted Date: August 5, 2021
• Actual Study Start Date: July 16, 2019
• Actual Primary Completion Date: June 2, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 1, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
• Official Title: Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Small Cell Lung Cancer

Intervention

Drug: LY3295668 Erbumine

oral capsules

Study Arms

• Experimental: LY3295668 Erbumine Cohort A
  LY3295668 erbumine administered orally.
  Intervention: Drug: LY3295668 Erbumine
• Experimental: LY3295668 Erbumine Cohort B
  LY3295668 erbumine administered orally.
  Intervention: Drug: LY3295668 Erbumine
• Experimental: LY3295668 Part JP
  LY3295668 erbumine administered orally.
  Intervention: Drug: LY3295668 Erbumine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2021): 48
• Original Estimated Enrollment (submitted: April 1, 2019): 64
• Actual Study Completion Date: March 30, 2021
• Actual Primary Completion Date: June 2, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Japan, Korea, Republic of, Spain, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT03898791
• Other Study ID Numbers: 17248; J1O-MC-JZHB ( Other Identifier: Eli Lilly and Company ); 2018-003485-14 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: https://vivli.org/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: July 2021