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

January 23, 2026 updated by: Eli Lilly and Company

A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire Sart Tilman
  • France
      • Toulouse, France, 31059
        • Hôpital Larrey
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59020
        • Centre Oscar Lambret
    • Hérault
      • Montpellier, Hérault, France, 34090
        • Hôpital Arnaud de Villeneuve - CHU Montpellier
  • Italy
      • Milan, Italy, 20132
        • Irccs Ospedale San Raffaele
    • Forli
      • Meldola, Forli, Italy, 47014
        • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
  • Spain
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Ávila, Spain, 05004
        • Hospital Nuestra Señora de Sonsoles
  • Taiwan
      • Neihu Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • New Taipei City, Taiwan, 235
        • Taipei Medical University- Shuang Ho Hospital
      • Tainan, Taiwan, 73657
        • Chi Mei Hospital - Liouying Branch
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi
      • Izmir, Turkey (Türkiye), 35100
        • Ege Universitesi Hastanesi
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group - Duplicate 2
    • California
      • San Francisco, California, United States, 94158
        • Univ of California San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcoma mutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); Part C: metastatic breast 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-based chemotherapy for advanced/metastatic NSCLC
    • Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
    • Part D: cannot have received endocrine therapy or chemotherapy as treatment in the locoregionally recurrent or metastatic breast cancer disease setting. Note: Participants may be enrolled if they received prior (neo)adjuvant chemotherapy or endocrine therapy for localized disease.
  • Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).
  • Have presence of measurable disease as defined by Response Evaluation Criteria in Solid 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 acute effects of therapy.
  • Have an estimated life expectancy of ≥12 weeks.
  • For Part D: Have postmenopausal status due to surgical/natural menopause or chemical ovarian suppression (initiated 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin or radiation-induced ovarian suppression.

Exclusion Criteria:

  • Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.
  • Have central nervous system (CNS) metastasis with development of associated neurological 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 requires systemic 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 for locoregionally recurrent or metastatic breast cancer. Note: A participant may be enrolled if she received prior (neo)adjuvant endocrine therapy (including, but not limited to anti-estrogens or aromatase inhibitors) for localized disease.
    • Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. Note: Participants may be enrolled if they received prior (neo)adjuvant chemotherapy for localized disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSCLC KRAS mt, PD-L1+
Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Pembrolizumab
Administered IV
Experimental: NSCLC Squamous
Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Pembrolizumab
Administered IV
Experimental: HR+, HER2- Metastatic Breast Cancer
Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Pembrolizumab
Administered IV
Experimental: HR+, HER2- Locally Advanced or Metastatic Breast Cancer
Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle and anastrozole given orally Q24H on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Pembrolizumab
Administered IV
Drug: Anastrozole
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Time Frame: Baseline through Study Treatment Completion (Approximately 6 Months)
Baseline through Study Treatment Completion (Approximately 6 Months)
Number of Participants with Non-Serious Adverse Event(s)
Time Frame: Baseline through Study Treatment Completion (Approximately 6 Months)
Baseline through Study Treatment Completion (Approximately 6 Months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response
Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Disease Control Rate (DCR) per RECIST v1.1: Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease
Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Duration of Response (DoR) per RECIST v1.1
Time Frame: Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 12 Months)
Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 12 Months)
Progression Free Survival (PFS) per RECIST v1.1
Time Frame: Baseline to Measured Progressive Disease or Death (Approximately 10 Months)
Baseline to Measured Progressive Disease or Death (Approximately 10 Months)
Overall Survival (OS)
Time Frame: Baseline to Date of Death Due to Any Cause (Approximately 18 Months)
Baseline to Date of Death Due to Any Cause (Approximately 18 Months)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib in Combination with Pembrolizumab with or without Anastrozole
Time Frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles)
Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Call 1-877-CTILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2016

Primary Completion (Actual)

February 3, 2020

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimated)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16177
  • I3Y-MC-JPCE (Other Identifier: Eli Lilly and Company)
  • 2015-005156-94 (EudraCT Number)
  • KEYNOTE 287 (Other Identifier: Merck)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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