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

Running, not enrolling · Phase 3

Conditions studied: Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02152631

Run by

Eli Lilly and Company

People needed

453

Starts

2014-10-03

Expected to finish

2026-12-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Bernards Medical Center — Jonesboro, Arkansas, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California - San Diego — La Jolla, California, United States
• Loma Linda University School of Medicine — Loma Linda, California, United States
• CBCC Global Research, Inc. — Los Angeles, California, United States
• Central Coast Medical Oncology Corporation — Los Angeles, California, United States
• Fort Wayne Oncology & Hematology — Los Angeles, California, United States
• SMO TRIO -Translational Research — Los Angeles, California, United States
• St. Joseph Heritage Medical Group — Los Angeles, California, United States
• UCLA Department of Medicine-Hematology/Oncology — Los Angeles, California, United States
• Cancer Care Associates Medical Group — Los Angeles, California, United States
• Dignity Health Care Institute — Sacramento, California, United States
• Alegent Immanuel Cancer Center — Englewood, Colorado, United States
• Jewish Hospital — Englewood, Colorado, United States
• Oncology Hematology West — Englewood, Colorado, United States
• SMO Catholic Health Initiatives — Englewood, Colorado, United States
• St Joseph Cancer Center — Englewood, Colorado, United States
• St. Francis Medical Center — Englewood, Colorado, United States
• Medical Oncology Hematology Consultants — Newark, Delaware, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Halifax Medical Center — Daytona Beach, Florida, United States
• Memorial Cancer Institute — Pembroke Pines, Florida, United States
• H Lee Moffitt Cancer Center — Tampa, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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