CompletedPhase 2NCT02450539

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

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.

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

StatusCompleted
PhasePhase 2
U.S. locations51
SponsorEli Lilly and Company
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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.

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

04
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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