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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAbemaciclib and Docetaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 13, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?51 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: Abemaciclib; Drug: Docetaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupFayetteville, Arkansas
Cancer Center of Kansas, P.A.Wichita, Kansas
Washington University School of MedicineSt Louis, Missouri
Montefiore Medical CenterThe Bronx, New York
Vista Oncology Inc. PSOlympia, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Camperdown
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Randwick
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.South Brisbane
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Wollongong
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Woolloongabba
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Paris
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Strasbourg

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 13, 2021. Always confirm current availability with the study team.

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