Clinical Trials in Italy / 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 Italy tracker
Condition(s) studied
Non Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
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
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.
More Eli Lilly and Company trials in Italy
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Active, not recruiting
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Active, not recruiting
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
Active, not recruiting
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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 Italy