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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02450539
First received: May 19, 2015
Last updated: May 18, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Non-Small Cell Lung Cancer Stage IV Drug: Abemaciclib Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Clearance of Abemaciclib [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 4 (Approximately 3 Months) ]
  • PK: Volume of Distribution of Abemaciclib [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 4 (Approximately 3 Months) ]
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 11 Months) ]
  • Percentage of Participants Who Achieve Complete Response or Partial Response: Overall Response Rate (ORR) [ Time Frame: Baseline to Objective Progression (Approximately 6 Months) ]
  • 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) ]
  • Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline up to Approximately 11 Months ]
  • Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score [ Time Frame: Baseline through End of Study (Approximately 6 Months) ]
  • 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) ]

Estimated Enrollment: 150
Study Start Date: August 2015
Estimated Study Completion Date: December 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02450539

  Show 51 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02450539     History of Changes
Other Study ID Numbers: 15806
I3Y-MC-JPBX ( Other Identifier: Eli Lilly and Company )
2014-004832-20 ( EudraCT Number )
Study First Received: May 19, 2015
Last Updated: May 18, 2017

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

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

ClinicalTrials.gov processed this record on September 19, 2017