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

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

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 Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Proportion of Participants Achieving Either Complete or Partial Response (Overall Response Rate)
  • Progression Free Survival (PFS)
  • Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of Abemaciclib
  • Change from Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score
  • Resource Utilization: Percentage of Participants Who are Hospitalized

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society