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

Status:	Active, not recruiting
Conditions:	Lung Cancer, Lung Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/3/2019
Start Date:	August 6, 2015
End Date:	August 14, 2019

A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

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.

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 measureable 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.

We found this trial at

sites

Vista Oncology Inc. PS

Olympia, Washington 98502

Principal Investigator: Joseph Ye

Phone: 360-352-2900

from

Olympia, WA