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A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (JUNIPER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02152631
First received: May 23, 2014
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: Abemaciclib Drug: Erlotinib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated Up to 47 Months) ]

Secondary Outcome Measures:
  • Proportion of Participants Achieving Either Complete or Partial Response (Overall Response Rate) [ Time Frame: Baseline to Objective Progression or Death from Any Cause (Estimated Up to 47 Months) ]
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death from Any Cause (Estimated Up to 47 Months) ]
  • Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score [ Time Frame: Baseline through End of Study (Estimated Up to 47 Months) ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of Abemaciclib [ Time Frame: Cycle 1 through Cycle 3 (28 Day Cycles) ]
  • Change from Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score [ Time Frame: Baseline through End of Study (Estimated Up to 47 Months) ]
  • Resource Utilization: Percentage of Participants Who are Hospitalized [ Time Frame: Baseline through End of Study (Estimated Up to 47 Months) ]

Estimated Enrollment: 450
Study Start Date: September 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abemaciclib
200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Active Comparator: Erlotinib
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Drug: Erlotinib
Administered orally

  Eligibility

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

Inclusion Criteria:

  • Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook.
  • Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study JPBK central laboratory. A KRAS positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per local laboratory will be permitted in no more than 10% of randomized participants.
  • Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible.
  • Have measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.

Exclusion Criteria:

  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
  • Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging [MRI]) within 28 days of randomization to document stability, even if there have been no changes in symptoms.
  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: NCT02152631

  Show 233 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02152631     History of Changes
Other Study ID Numbers: 15296
I3Y-MC-JPBK ( Other Identifier: Eli Lilly and Company )
2013-004662-33 ( EudraCT Number )
Study First Received: May 23, 2014
Last Updated: March 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
Therapy, Platinum, Kras +

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
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2017