NCT02450539

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2

Geographic Reach
13 countries

51 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 26, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
Last Updated

August 13, 2021

Status Verified

July 15, 2021

Enrollment Period

1.7 years

First QC Date

May 19, 2015

Results QC Date

March 30, 2018

Last Update Submit

July 26, 2021

Conditions

Non-Small Cell Lung Cancer Stage IV

Keywords

patient reported outcomes (PRO)patient focused outcomes (PFO)biomarkersCDK 4 and 6

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

    Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)

Secondary Outcomes (9)

  • Pharmacokinetics (PK): Clearance of Abemaciclib

    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

  • PK: Volume of Distribution of Abemaciclib

    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

  • Overall Survival (OS)

    Baseline to Date of Death from Any Cause (Up To 28 Months)

  • Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

    Baseline to Objective Progression (Up To 6 Months)

  • Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

    Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)

  • +4 more secondary outcomes

Study Arms (2)

Abemaciclib

EXPERIMENTAL

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.

Drug: Abemaciclib

Docetaxel

ACTIVE COMPARATOR

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.

Drug: Docetaxel

Interventions

AbemaciclibDRUG

Administered orally

Also known as: LY2835219
Abemaciclib
DocetaxelDRUG

Administered IV

Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67214, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Vista Oncology Inc. PS

Olympia, Washington, 98502, United States

Location

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, 2050, Australia

Location

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Randwick, 2013, Australia

Location

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South Brisbane, 4101, Australia

Location

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Wollongong, 2500, Australia

Location

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Woolloongabba, 4102, Australia

Location

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Paris, 75970, France

Location

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Strasbourg, 67091, France

Location

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Suresnes, 92150, France

Location

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Berlin, 14165, Germany

Location

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Cologne, 51109, Germany

Location

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Gera, 07548, Germany

Location

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Halle, 06120, Germany

Location

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Heidelberg, 69126, Germany

Location

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Budapest, 1121, Hungary

Location

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Győr, 9023, Hungary

Location

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Bari, 70124, Italy

Location

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Florence, 50134, Italy

Location

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Monza, 20900, Italy

Location

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Torino, 10043, Italy

Location

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Krakow, 31-202, Poland

Location

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Lodz, 90-242, Poland

Location

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Olsztyn, 10-357, Poland

Location

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Poznan, 60-569, Poland

Location

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Warsaw, 04-125, Poland

Location

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Baia Mare, 430031, Romania

Location

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Cluj-Napoca, 400015, Romania

Location

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Cluj-Napoca, 400058, Romania

Location

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Craiova, 200347, Romania

Location

St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)

Saint Petersburg, 197758, Russia

Location

Volgograd regional clinical oncology dispensary

Volzhsky, 404130, Russia

Location

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.

Cheongju-si, 28644, South Korea

Location

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Seoul, 06351, South Korea

Location

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Seoul, 06591, South Korea

Location

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Ulsan, 44033, South Korea

Location

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Barcelona, 08025, Spain

Location

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Madrid, 28223, Spain

Location

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Pamplona, 31008, Spain

Location

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Seville, 41071, Spain

Location

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Taichung, 40447, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Tainan, 70403, Taiwan

Location

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Taipei, 10048, Taiwan

Location

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Dnipropetrovsk, 49102, Ukraine

Location

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Kharkiv, 61070, Ukraine

Location

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Kryvyi Rih, 50048, Ukraine

Location

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Vinnitsa, 21029, Ukraine

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

abemaciclibDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

August 6, 2015

Primary Completion

March 31, 2017

Study Completion

July 29, 2020

Last Updated

August 13, 2021

Results First Posted

June 26, 2018

Record last verified: 2021-07-15

Data Sharing

IPD Sharing
Will share

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.

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.
More information

Locations

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