A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer (NCT02450539) | Clinical Trial Compass
CompletedPhase 2
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
United States159 participantsStarted 2015-08-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)