A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2020-07-29
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Confirmed diagnosis of stage IV NSCLC.

• Have progressed during or after platinum-based chemotherapy for advanced disease.

• Have not received prior treatment with docetaxel.

• Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.

• Have adequate organ function including hematology, renal, and liver.

• Have good performance score (0-1).

• Have measurable disease per RECIST 1.1.

• Agree to use a reliable medically approved method of birth control.

Exclusion Criteria:

• Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known.

• Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.

• Have the presence of unstable central nervous system (CNS) metastasis.

• Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.