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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT02152631
• Date of registration: 23/05/2014
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer JUNIPER
• Scientific 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
• Date of first enrolment: October 3, 2014
• Target sample size: 453
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02152631
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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 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.

- Have previously completed or withdrawn from this study or any other study
investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6)
inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer

Intervention(s)

Drug: Erlotinib

Drug: Abemaciclib

Primary Outcome(s)

Overall Survival (OS) [Time Frame: From Randomization Date to Date of Death from Any Cause (Up to 32 Months)]

Secondary Outcome(s)

Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score [Time Frame: From Randomization Date through End of Study (Up to 32 Months)]

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State [Time Frame: Day 1 of 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: From Randomization Date through End of Study (Up to 32 Months)]

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [Time Frame: From Randomization Date to Objective Progression (Up to 32 Months)]

Resource Utilization: Percentage of Participants Who Are Hospitalized [Time Frame: From Randomization Date through End of Study (Up to 32 Months)]

Progression Free Survival (PFS) [Time Frame: From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months)]

Secondary ID(s)

I3Y-MC-JPBK

2013-004662-33

15296

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02152631