Small Cell Lung CancerPhase 1NCT03898791
A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
A Phase 1 study testing LY3295668 Erbumine in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 40 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- LY3295668 Erbumine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 40 sitesin 8 countries
- Study dates
- 16 Jul 2019to 30 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 8 countries.
40 sites in 8 countries
United States16 sites
Texas Oncology Cancer Center
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, 28204
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Texas Oncology Fort Worth
Fort Worth, Texas, 76104
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Washington University Medical School
St Louis, Missouri, 63110
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
US Oncology
The Woodlands, Texas, 77380
Tyler Cancer Center
Tyler, Texas, 75702
France6 sites
Institut Bergonie
Bordeaux, 33076
Centre Georges Francois Leclerc
Dijon, 21000
Centre de Lutte Contre le Cancer Leon Berard
Lyon, 69373
APHM Hôpital de la Timone
Marseille, 13385
Institut Curie
Paris, 75248
Institut de Cancérologie de l'Ouest Centre René Gauducheau
Saint-Herblain, 44805
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital Universitario La Fe de Valencia
Valencia, 46026
Belgium4 sites
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, 6000
Universitair Ziekenhuis Gent
Ghent, 9000
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
AZ Delta
Roeselare, 8800
South Korea3 sites
Severance Hospital Yonsei University Health System
Seoul, Korea, 03722
Samsung Medical Center
Seoul, Korea, 06351
Asan Medical Center
Seoul, 05505
Turkey (Türkiye)2 sites
Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
Ankara, 06200
Ege University Faculty of Medicine
Izmir, 35100
United Kingdom2 sites
Guys/St. Thomas Hospital
London, Surrey, SE1 9RT
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- LY3295668 Erbumine
- Keywords
- aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA
- Medical subject headings
- Small Cell Lung Carcinoma, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3295668 ErbumineDrug
oral capsules
| Study group | Role | What they receive |
|---|---|---|
| LY3295668 Erbumine Cohort A | Experimental | LY3295668 erbumine administered orally. Receives: Drug: LY3295668 Erbumine |
| LY3295668 Erbumine Cohort B | Experimental | LY3295668 erbumine administered orally. Receives: Drug: LY3295668 Erbumine |
| LY3295668 Part JP | Experimental | LY3295668 erbumine administered orally. Receives: Drug: LY3295668 Erbumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Reductions
Number of Participants with Dose Reductions
Measured: 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
Measured: 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
Measured: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Duration of Response (DoR)
DoR
Measured: 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
PK: Cmax of LY3295668 Erbumine
Measured: 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
Measured: 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
Measured: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start16 Jul 2019
- Primary completion2 Jun 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898791
- Sponsor's protocol ID
- 17248
- Other IDs
- J1O-MC-JZHB, 2018-003485-14, 2018
- Status last verified
- Jul 2021
- First submitted
- 1 Apr 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03898791
- Acronym / sponsor ID
- 17248
- Conditions
- Small Cell Lung Cancer
- Keywords
- aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3295668 Erbumine Cohort A | Experimental | Drug: LY3295668 ErbumineLY3295668 erbumine administered orally. |
| LY3295668 Erbumine Cohort B | Experimental | Drug: LY3295668 ErbumineLY3295668 erbumine administered orally. |
| LY3295668 Part JP | Experimental | Drug: LY3295668 ErbumineLY3295668 erbumine administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3295668 Erbumineoral capsules | Drug | LY3295668 Erbumine Cohort A, LY3295668 Erbumine Cohort B, LY3295668 Part JP |
Primary outcome
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
3 secondary outcomes
PK: Maximum Concentration (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)
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
Time frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
40 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3295668 Erbumine in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 40 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, France, Spain, Belgium, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Reductions (time frame: Baseline through Cycle 1 (28 Day Cycle)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.