A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02450539
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Stage IV Drug: Abemaciclib Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2015
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
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.
Drug: Docetaxel
Administered IV

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death from Any Cause (Approximately 6 Months) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02450539

  Show 51 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Responsible Party: Eli Lilly and Company Identifier: NCT02450539     History of Changes
Other Study ID Numbers: 15806
I3Y-MC-JPBX ( Other Identifier: Eli Lilly and Company )
2014-004832-20 ( EudraCT Number )
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Eli Lilly and Company:
patient reported outcomes (PRO)
patient focused outcomes (PFO)
CDK 4 and 6

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action