Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02450539
Ethics application status
Date submitted
19/05/2015
Date registered
19/05/2015
Date last updated
18/05/2017

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
Scientific title
A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Secondary ID [1] 0 0
I3Y-MC-JPBX
Secondary ID [2] 0 0
15806
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer Stage IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - Abemaciclib
Treatment: drugs - Docetaxel

Experimental: Abemaciclib - Abemaciclib given orally every 12 hours on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Active Comparator: Docetaxel - Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.


Treatment: drugs: Abemaciclib
Administered orally

Treatment: drugs: Docetaxel
Administered IV

Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline to Objective Progression or Death from Any Cause (Approximately 6 Months)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Clearance of Abemaciclib
Timepoint [1] 0 0
Predose Day 1 Cycle 1 through Predose Day 1 Cycle 4 (Approximately 3 Months)
Secondary outcome [2] 0 0
PK: Volume of Distribution of Abemaciclib
Timepoint [2] 0 0
Predose Day 1 Cycle 1 through Predose Day 1 Cycle 4 (Approximately 3 Months)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to Date of Death from Any Cause (Approximately 11 Months)
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve Complete Response or Partial Response: Overall Response Rate (ORR)
Timepoint [4] 0 0
Baseline to Objective Progression (Approximately 6 Months)
Secondary outcome [5] 0 0
Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)
Timepoint [5] 0 0
Baseline through Measured Progressive Disease (Approximately 6 Months)
Secondary outcome [6] 0 0
Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [6] 0 0
Baseline up to Approximately 11 Months
Secondary outcome [7] 0 0
Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score
Timepoint [7] 0 0
Baseline through End of Study (Approximately 6 Months)
Secondary outcome [8] 0 0
Change from Baseline in EuroQol 5-Dimensional 5 Level (EQ-5D-5L) Questionnaire Index Score
Timepoint [8] 0 0
Baseline to Measured Progressive Disease (Approximately 6 Months)

Eligibility
Key inclusion criteria
- Confirmed diagnosis of stage IV NSCLC.

- Have progressed during or after platinum-based chemotherapy for advanced disease.

- Have not received prior treatment with docetaxel.

- Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived
material.

- Have adequate organ function including hematology, renal, and liver.

- Have good performance score (0-1).

- Have measureable disease per RECIST 1.1.

- Agree to use a reliable medically approved method of birth control.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor
or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment
administered is not known.

- Are currently receiving treatment in a clinical trial involving an investigational
product or non-approved use of a drug or device.

- Have the presence of unstable central nervous system (CNS) metastasis.

- Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Camperdown
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Randwick
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - South Brisbane
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2013 - Randwick
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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Kansas
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Washington
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France
State/province [6] 0 0
Paris
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France
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Strasbourg
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France
State/province [8] 0 0
Suresnes
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Germany
State/province [9] 0 0
Berlin
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Germany
State/province [10] 0 0
Gera
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Koln
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Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Gyor
Country [16] 0 0
Italy
State/province [16] 0 0
Bari
Country [17] 0 0
Italy
State/province [17] 0 0
Firenze
Country [18] 0 0
Italy
State/province [18] 0 0
Monza
Country [19] 0 0
Italy
State/province [19] 0 0
Torino
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Cheongju
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Korea, Republic of
State/province [21] 0 0
Seoul
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Korea, Republic of
State/province [22] 0 0
Ulsan-si
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Olsztyn
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Poland
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Poznan
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Poland
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Warszawa
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Romania
State/province [28] 0 0
Baia Mare
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Romania
State/province [29] 0 0
Cluj-Napoca
Country [30] 0 0
Romania
State/province [30] 0 0
Craiova
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Russian Federation
State/province [31] 0 0
St Petersburg
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Russian Federation
State/province [32] 0 0
Volzhsky
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Spain
State/province [33] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sevilla
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Taiwan
State/province [37] 0 0
Taichung
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Taiwan
State/province [38] 0 0
Tainan
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Taiwan
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Taipei
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
State/province [42] 0 0
Kriviy Rig
Country [43] 0 0
Ukraine
State/province [43] 0 0
Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to evaluate the effectiveness of the study drug known as
abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung
cancer (NSCLC) previously treated with platinum-based chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information