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

NCT02152631 Phase 3 ACTIVE_NOT_RECRUITING Results posted

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.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	453
Start date	2014-10-03
Completion	2026-12

Conditions

• Non Small Cell Lung Cancer

Interventions

• Abemaciclib
• Erlotinib

Primary outcomes

• Overall Survival (OS) — From Randomization Date to Date of Death from Any Cause (Up to 32 Months)
  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.

Countries

United States, Argentina, Austria, Brazil, Canada, China, France, Germany, Greece, Israel, Italy, Japan, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine