Study on Abemaciclib for Patients with Previously Treated KRAS Mutated Lung Cancer

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT02152631

This clinical trial is testing the safety and effectiveness of a drug called abemaciclib in patients with lung cancer that has a specific KRAS mutation and has been previously treated.

Patient Parameters

Program Overview

The purpose of this study is to find out how safe and effective the drug abemaciclib is for patients with lung cancer that has a specific mutation in the KRAS gene. This study is for patients whose cancer has already been treated with other therapies.

Eligibility Criteria

Inclusion Criteria

  • Have stage IV non-small cell lung cancer (NSCLC) confirmed by medical guidelines.
  • Have a specific mutation in the KRAS gene, identified by a special test.
  • Have cancer that has worsened after receiving platinum-based chemotherapy and at least one other treatment, which could include immunotherapy or other cancer drugs.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have stopped all previous cancer treatments for at least 21 days for certain drugs or 14 days for others before starting the study drug.

Exclusion Criteria

  • Have taken a drug not approved by health authorities within 14 or 21 days before starting the study drug, depending on the type of drug.
  • Have a history of fainting or heart rhythm problems, or have had a sudden cardiac arrest.
  • Have unstable cancer that has spread to the brain or spinal cord. Stable brain metastases are allowed if they do not require active treatment and have been confirmed stable by a brain scan within 28 days before starting the study.
  • Have previously participated in this study or any other study involving CDK4 and CDK6 inhibitors, or have been treated with these types of drugs before.

Locations

FACILITYZIPCITYSTATE
Highlands Oncology Group72703FayettevilleArkansas
St. Bernards Medical Center72401JonesboroArkansas
City of Hope National Medical Center91010DuarteCalifornia
University of California - San Diego92037La JollaCalifornia
Loma Linda University School of Medicine92350Loma LindaCalifornia
CBCC Global Research, Inc.90024Los AngelesCalifornia
Central Coast Medical Oncology Corporation90024Los AngelesCalifornia
Fort Wayne Oncology & Hematology90024Los AngelesCalifornia
SMO TRIO -Translational Research90024Los AngelesCalifornia
St. Joseph Heritage Medical Group90024Los AngelesCalifornia

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