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Clinical Trials in China / NCT02152631
Active, not recruiting Phase 3

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

NCT02152631 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2014-10-03
Last updated
2026-02-06

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

AbemaciclibErlotinib

Abemaciclib: Administered orally

Erlotinib: Administered orally

Study summary

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)

Trial sites (231)

FacilityCityRegionStatus
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.

On this site

📄 Verzenio (abemaciclib) drug profile → 📄 Tarceva (erlotinib) drug profile →

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

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.

View NCT02152631 on ClinicalTrials.gov ↗ ← All trials in China