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:1/6/2019
Start Date:August 6, 2015
End Date:February 14, 2019

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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
6
sites
Fayetteville, Arkansas 72703
Principal Investigator: Eric Schaefer
Phone: 479-587-1700
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Fayetteville, AR
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Camperdown,
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Olympia, Washington 98502
Principal Investigator: Joseph Ye
Phone: 360-352-2900
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Olympia, WA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Ramaswamy Govindan
Phone: 314-362-5737
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
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Saint Louis, MO
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Wichita, KS
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