For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.
CDK4 & 6 Inhibitor
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*
Key Inclusion Criteria
- Stage IV non-small cell lung cancer (NSCLC)
- Detectable mutations in codons 12 or 13 of the KRAS oncogene by an investigational assay at the central study 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 the randomized patients
- Must have progressed after platinum-based chemotherapy (with or without maintenance therapy) and have received one additional therapy that may include an immune checkpoint inhibitor or other anticancer therapy for advanced and/or metastatic disease, or is judged by the physician as ineligible for further standard second-line chemotherapy
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Discontinuation of all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 or 14 days for myelosuppressive or nonmyelosuppressive agents, respectively, prior to receiving study drug
Key Exclusion Criteria
- Prior 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
- History of 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
- Presence of unstable central nervous system (CNS) metastasis. Histories of CNS metastasis or stable CNS metastases are allowed (if no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (eg, magnetic resonance imaging) within 28 days of randomization to document stability, even if there have been no changes in symptoms
- Prior completion or withdrawal from this or any other study investigating a CDK4 & 6 inhibitor, or received prior treatment with a CDK4 & 6 inhibitor
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.