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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer Stage IV

Treatments: Drug: Abemaciclib; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02450539

2014-004832-20 (EudraCT Number)

I3Y-MC-JPBX (Other Identifier)

15806

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Abemaciclib

Experimental group

Description:

200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Treatment:

Drug: Abemaciclib

Docetaxel

Active Comparator group

Description:

75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Treatment:

Drug: Docetaxel