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

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.
ClinicalTrials.gov Identifier: NCT02152631
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):

May 23, 2014
June 2, 2014
October 19, 2017
October 2014
September 2017   (Final data collection date for primary outcome measure)
Overall Survival (OS) [ Time Frame: Baseline to Date of 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 34 Months) ]
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated Up to 34 Months) ]
Complete list of historical versions of study NCT02152631 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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 34 Months) ]
  • Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score [ Time Frame: Baseline through End of Study (Estimated Up to 34 Months) ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2835219 [ 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 34 Months) ]
  • Resource Utilization: Percentage of Participants Who are Hospitalized [ Time Frame: Baseline through End of Study (Estimated Up to 34 Months) ]
Not Provided
Not Provided
 
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Abemaciclib
    Administered orally
    Other Name: LY2835219
  • Drug: Erlotinib
    Administered orally
  • Experimental: Abemaciclib
    200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).
    Intervention: Drug: Abemaciclib
  • Active Comparator: Erlotinib
    150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
    Intervention: Drug: Erlotinib
Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
November 2018
September 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Brazil,   Canada,   China,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
 
 
NCT02152631
15296
I3Y-MC-JPBK ( Other Identifier: Eli Lilly and Company )
2013-004662-33 ( EudraCT Number )
Yes
Not Provided
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.

Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP