A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

Last updated: January 23, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

Breast Cancer

Cancer

Treatment

Abemaciclib

Anastrozole

Pembrolizumab

Clinical Study ID

NCT02779751
16177
2015-005156-94
I3Y-MC-JPCE
KEYNOTE 287
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcomamutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); Part C: metastaticbreast cancer (HR+, HER2-); or Part D: locally advanced or metastatic breast cancer (HR+, HER2-)

  • Part A: must be chemotherapy naïve for metastatic NSCLC

  • Part B: must have received at least 1 prior therapy containing platinum-basedchemotherapy for advanced/metastatic NSCLC

  • Part C: must have previously received prior treatment with at least 1 but nomore than 2 chemotherapy regimens in the metastatic setting

  • Part D: cannot have received endocrine therapy or chemotherapy as treatment inthe locoregionally recurrent or metastatic breast cancer disease setting. Note:Participants may be enrolled if they received prior (neo)adjuvant chemotherapyor endocrine therapy for localized disease.

  • Are amenable to provide tumor tissue prior to treatment and provide tumor tissueafter treatment initiation (both mandatory).

  • Have presence of measurable disease as defined by Response Evaluation Criteria inSolid Tumors (RECIST 1.1).

  • Have a performance status (PS) ≤1 on the Eastern Cooperative Oncology Group (ECOG)scale.

  • Have discontinued all previous treatments for cancer and recovered from the acuteeffects of therapy.

  • Have an estimated life expectancy of ≥12 weeks.

  • For Part D: Have postmenopausal status due to surgical/natural menopause or chemicalovarian suppression (initiated 28 days prior to Day 1 of Cycle 1) with agonadotropin-releasing hormone (GnRH) agonist such as goserelin or radiation-inducedovarian suppression.

Exclusion

Exclusion Criteria:

  • Have a personal history of any of the following conditions: syncope of eitherunexplained or cardiovascular etiology, ventricular arrhythmia (including but notlimited to ventricular tachycardia and ventricular fibrillation), or sudden cardiacarrest. Exception: subjects with controlled atrial fibrillation for >30 days priorto study treatment are eligible.

  • Have central nervous system (CNS) metastasis with development of associatedneurological changes 14 days prior to receiving study drug.

  • Have corrected QT interval of >470 milliseconds on screening electrocardiogram (ECG).

  • Have history of interstitial lung disease or pneumonitis.

  • Have history of or active autoimmune disease, or other syndrome that requiressystemic steroids or autoimmune agents for the past 2 years.

  • Have received a live vaccination within 30 days of study start.

  • Have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.

  • For Part D Only:

  • Have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to Cycle 1 Day 1.

  • Are currently receiving or have previously received endocrine therapy forlocoregionally recurrent or metastatic breast cancer. Note: A participant maybe enrolled if she received prior (neo)adjuvant endocrine therapy (including,but not limited to anti-estrogens or aromatase inhibitors) for localizeddisease.

  • Are currently receiving or have previously received chemotherapy forlocoregionally recurrent or metastatic breast cancer. Note: Participants may beenrolled if they received prior (neo)adjuvant chemotherapy for localizeddisease.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Abemaciclib
Phase: 1
Study Start date:
November 14, 2016
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire Sart Tilman

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Centre Oscar Lambret

    Lille 2998324, Hauts-de-France 11071624 59020
    France

    Site Not Available

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault 34090
    France

    Site Not Available

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier 2992166, Hérault 34090
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, Nord-Pas-de-Calais 59020
    France

    Site Not Available

  • 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.

    Lille, 59020
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille Cedex, 59020
    France

    Site Not Available

  • 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.

    Montpellier, 34295
    France

    Site Not Available

  • CHU de Montpellier-Hopital Arnaud de Villeneuve

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Hopital Larrey

    Toulouse, 31059
    France

    Site Not Available

  • Hopital Larrey

    Toulouse 2972315, 31059
    France

    Site Not Available

  • 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.

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

    Meldola, Forli 47014
    Italy

    Site Not Available

  • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

    Meldola 3173635, Forli 47014
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milan 6951411, 20132
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Hospital Nuestra Senora de Sonsoles

    Avila, 05004
    Spain

    Site Not Available

  • Nuestra Senora de Sonsoles

    Avila, 05004
    Spain

    Site Not Available

  • Hospital San Pedro de Alcantara

    Caceres, 10003
    Spain

    Site Not Available

  • Hospital San Pedro de Alcantara

    Cáceres 2520611, 10003
    Spain

    Site Not Available

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Madrid Norte Sanchinarro

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hospital Nuestra Senora de Sonsoles

    Ávila 3129136, 05004
    Spain

    Site Not Available

  • 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.

    Jhonghe City, 235
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Neihu Taipei, 114
    Taiwan

    Site Not Available

  • Taipei Medical University- Shuang Ho Hospital

    New Taipei City, 235
    Taiwan

    Site Not Available

  • Taipei Medical University- Shuang Ho Hospital

    New Taipei City 12908892, 235
    Taiwan

    Site Not Available

  • Chi Mei Hospital - Liouying Branch

    Tainan, 73657
    Taiwan

    Site Not Available

  • Chi-Mei Meical Center, Liouying

    Tainan, 73657
    Taiwan

    Site Not Available

  • Chi Mei Hospital - Liouying Branch

    Tainan 1668355, 73657
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10048
    Taiwan

    Site Not Available

  • 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.

    Antalya, 07059
    Turkey

    Site Not Available

  • 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

    Edirne, 22030
    Turkey

    Site Not Available

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098
    Turkey

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Site Not Available

  • Ege Universitesi Hastanesi

    Izmir, 35100
    Turkey

    Site Not Available

  • Ege University Faculty of Medicine

    Izmir, 35100
    Turkey

    Site Not Available

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul 745044, 34098
    Turkey (Türkiye)

    Site Not Available

  • Ege Universitesi Hastanesi

    Izmir 311046, 35100
    Turkey (Türkiye)

    Site Not Available

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Highlands Oncology Group - Duplicate 2

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Highlands Oncology Group - Duplicate 2

    Springdale 4132093, Arkansas 4099753 72762
    United States

    Site Not Available

  • Univ of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Univ of California San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • University of Colorado School of Medicine

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado School of Medicine

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

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