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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Overall Survival (OS) — 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.
Trial sites (231)
Facility
City
Region
Status
Highlands Oncology Group
Fayetteville
Arkansas
St. Bernards Medical Center
Jonesboro
Arkansas
City of Hope National Medical Center
Duarte
California
University of California - San Diego
La Jolla
California
Loma Linda University School of Medicine
Loma Linda
California
CBCC Global Research, Inc.
Los Angeles
California
Central Coast Medical Oncology Corporation
Los Angeles
California
Fort Wayne Oncology & Hematology
Los Angeles
California
SMO TRIO -Translational Research
Los Angeles
California
St. Joseph Heritage Medical Group
Los Angeles
California
UCLA Department of Medicine-Hematology/Oncology
Los Angeles
California
Cancer Care Associates Medical Group
Los Angeles
California
Dignity Health Care Institute
Sacramento
California
Alegent Immanuel Cancer Center
Englewood
Colorado
Jewish Hospital
Englewood
Colorado
Oncology Hematology West
Englewood
Colorado
SMO Catholic Health Initiatives
Englewood
Colorado
St Joseph Cancer Center
Englewood
Colorado
St. Francis Medical Center
Englewood
Colorado
Medical Oncology Hematology Consultants
Newark
Delaware
Boca Raton Regional Hospital
Boca Raton
Florida
Halifax Medical Center
Daytona Beach
Florida
Memorial Cancer Institute
Pembroke Pines
Florida
H Lee Moffitt Cancer Center
Tampa
Florida
University Cancer & Blood Center, LLC
Athens
Georgia
Ingalls Memorial Hospital
Harvey
Illinois
Indiana University School of Medicine
Indianapolis
Indiana
University of Iowa
Iowa City
Iowa
Cancer Center of Kansas, P.A.
Wichita
Kansas
Central Baptist Hospital
Lexington
Kentucky
University of Louisville
Louisville
Kentucky
Walter Reed National Military Medical Center
Bethesda
Maryland
Metro-West and Greater Boston CNS Research
Framingham
Massachusetts
Karmanos Cancer Institute
Detroit
Michigan
Mercy Medical Research Institute
Springfield
Missouri
Billings Clinic Research Center
Billings
Montana
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
Broome Oncology
Johnson City
New York
Weill Cornell Medical College
New York
New York
Oncology Hematology Care Inc
Cincinnati
Ohio
+ 191 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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