A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
3 other identifiers
interventional
48
8 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2019
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedAugust 5, 2021
July 1, 2021
11 months
April 1, 2019
July 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
PK: Maximum Concentration (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)
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
Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Study Arms (3)
LY3295668 Erbumine Cohort A
EXPERIMENTALLY3295668 erbumine administered orally.
LY3295668 Erbumine Cohort B
EXPERIMENTALLY3295668 erbumine administered orally.
LY3295668 Part JP
EXPERIMENTALLY3295668 erbumine administered orally.
Interventions
oral capsules
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
H Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
Texas Oncology Cancer Center
Austin, Texas, 78705, United States
Texas Oncology Fort Worth
Fort Worth, Texas, 76104, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
US Oncology
The Woodlands, Texas, 77380, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, 6000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Institut Bergonie
Bordeaux, 33076, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Centre de Lutte Contre le Cancer Leon Berard
Lyon, 69373, France
APHM Hôpital de la Timone
Marseille, 13385, France
Institut Curie
Paris, 75248, France
Institut de Cancérologie de l'Ouest Centre René Gauducheau
Saint-Herblain, 44805, France
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
Severance Hospital Yonsei University Health System
Seoul, Korea, 03722, South Korea
Samsung Medical Center
Seoul, Korea, 06351, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
Ankara, 06200, Turkey (Türkiye)
Ege University Faculty of Medicine
Izmir, 35100, Turkey (Türkiye)
Guys/St. Thomas Hospital
London, Surrey, SE1 9RT, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 2, 2019
Study Start
July 16, 2019
Primary Completion
June 2, 2020
Study Completion
March 30, 2021
Last Updated
August 5, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.