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 Japan K.K.0 个研究点开始时间: 2014年10月22日最近更新: 2023年10月17日

适应症

试验速览

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•The participants must 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 KRAS oncogene by an investigational assay at the study JPBK central laboratory.
•- The participant must have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one other prior chemotherapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy.
•- 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.

•- 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, or sudden cardiac arrest.
•- Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases are allowed (no longer requiring active therapy such as steroid medications).

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