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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02450539




Registration number
NCT02450539
Ethics application status
Date submitted
19/05/2015
Date registered
21/05/2015

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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Docetaxel

Experimental: Abemaciclib - 200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Active comparator: Docetaxel - 75 milligram per meter squared (mg/m²) 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 ( Up To 6 Months)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Clearance of Abemaciclib
Timepoint [1] 0 0
Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Secondary outcome [2] 0 0
PK: Volume of Distribution of Abemaciclib
Timepoint [2] 0 0
Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to Date of Death from Any Cause (Up To 28 Months)
Secondary outcome [4] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Timepoint [4] 0 0
Baseline to Objective Progression (Up To 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 or Death Due to Any Cause (Up To 6 Months)
Secondary outcome [6] 0 0
Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2
Timepoint [6] 0 0
Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)
Secondary outcome [7] 0 0
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores
Timepoint [7] 0 0
Baseline through End of Study (Up To 6 Months)
Secondary outcome [8] 0 0
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score
Timepoint [8] 0 0
Baseline to Measured Progressive Disease (Up To 6 Months)
Secondary outcome [9] 0 0
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value
Timepoint [9] 0 0
Baseline to Measured Progressive Disease (Up To 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 measurable disease per RECIST 1.1.
* Agree to use a reliable medically approved method of birth control.
Minimum age
18 Years
Maximum age
No limit
Sex
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
Open (masking not 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/07/2020
Sample size
Target
Accrual to date
Final
159
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Strasbourg
Country [8] 0 0
France
State/province [8] 0 0
Suresnes
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Gera
Country [11] 0 0
Germany
State/province [11] 0 0
Halle
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Germany
State/province [13] 0 0
Koln
Country [14] 0 0
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
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Ulsan-si
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Lodz
Country [25] 0 0
Poland
State/province [25] 0 0
Olsztyn
Country [26] 0 0
Poland
State/province [26] 0 0
Poznan
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Romania
State/province [28] 0 0
Baia Mare
Country [29] 0 0
Romania
State/province [29] 0 0
Cluj-Napoca
Country [30] 0 0
Romania
State/province [30] 0 0
Craiova
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St Petersburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Volzhsky
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Pamplona
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taichung
Country [38] 0 0
Taiwan
State/province [38] 0 0
Tainan
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Ukraine
State/province [40] 0 0
Dnipropetrovsk
Country [41] 0 0
Ukraine
State/province [41] 0 0
Kharkiv
Country [42] 0 0
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
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02450539