NCT02152631|Active Not RecruitingPhase 3ResultsDMC

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

JUNIPER

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

Eli Lilly and Company ClinicalTrials.gov

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3 other identifiers

15296I3Y-MC-JPBK2013-004662-33

Study Type

interventional

Target

453

Locations

21 countries

Sites

231

Timeline

RegisteredJun 2014

StartedOct 2014

CompletionDec 2026

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

453

participants targeted

Target at P50-P75 for phase_3

Timeline

7mo left

Started Oct 2014

Longer than P75 for phase_3

Geographic Reach

21 countries

231 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.2 years study duration

Study Progress95%

Oct 2014Dec 2026

First Submitted

Initial submission to the registry

May 23, 2014

Completed

10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed

4 months until next milestone

Study Start

First participant enrolled

October 3, 2014

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

December 12, 2018

Completed

8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

May 23, 2014

Results QC Date

August 23, 2018

Last Update Submit

January 19, 2026

Conditions

Non Small Cell Lung Cancer

Keywords

Therapy, Platinum, Kras +

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
From Randomization Date to Date of Death from Any Cause (Up to 32 Months)

Secondary Outcomes (6)

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
From Randomization Date to Objective Progression (Up to 32 Months)
Progression Free Survival (PFS)
From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months)
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score
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
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
From Randomization Date through End of Study (Up to 32 Months)
+1 more secondary outcomes

Study Arms (2)

Abemaciclib

EXPERIMENTAL

200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).

Drug: Abemaciclib

Erlotinib

ACTIVE COMPARATOR

150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).

Drug: Erlotinib

Interventions

AbemaciclibDRUG

Administered orally

Also known as: LY2835219

Abemaciclib

ErlotinibDRUG

Administered orally

Erlotinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (231)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California - San Diego

La Jolla, California, 92037, United States

Location

Loma Linda University School of Medicine

Loma Linda, California, 92350, United States

Location

CBCC Global Research, Inc.