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 Company231 个研究点分布在 1 个国家目标入组 453 人2014年10月3日

适应症Non Small Cell Lung Cancer

干预措施Abemaciclib Erlotinib

概览

阶段: 3 期
干预措施: Abemaciclib
疾病 / 适应症: Non Small Cell Lung Cancer
发起方: Eli Lilly and Company
入组人数: 453
试验地点: 231
主要终点: Overall Survival (OS)
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2014年10月3日

结束日期

2026年12月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Eli Lilly and Company

责任方

Sponsor

入排标准

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Abemaciclib

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

干预措施: Abemaciclib

Erlotinib

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

干预措施: Erlotinib

结局指标

主要结局

Overall Survival (OS)

时间窗: 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.

次要结局

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