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

NCT02779751 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: 16177I3Y-MC-JPCE2015-005156-94KEYNOTE 287
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 24

Brief 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.

Conditions

Non Small Cell Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs)

  Baseline through Study Treatment Completion (Approximately 6 Months)

• Number of Participants with Non-Serious Adverse Event(s)

  Baseline through Study Treatment Completion (Approximately 6 Months)

Secondary Outcomes (6)

• Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response

  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

  Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)

• Duration of Response (DoR) per RECIST v1.1

  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

  Baseline to Measured Progressive Disease or Death (Approximately 10 Months)

• Overall Survival (OS)

  Baseline to Date of Death Due to Any Cause (Approximately 18 Months)

Study Arms (4)

NSCLC KRAS mt, PD-L1+

EXPERIMENTAL

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; Drug: Pembrolizumab

NSCLC Squamous

EXPERIMENTAL

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; Drug: Pembrolizumab

HR+, HER2- Metastatic Breast Cancer

EXPERIMENTAL

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; Drug: Pembrolizumab

HR+, HER2- Locally Advanced or Metastatic Breast Cancer

EXPERIMENTAL

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; Drug: Pembrolizumab; Drug: Anastrozole

Interventions

Abemaciclib DRUG

Administered orally

Also known as: LY2835219

HR+, HER2- Locally Advanced or Metastatic Breast Cancer; HR+, HER2- Metastatic Breast Cancer; NSCLC KRAS mt, PD-L1+; NSCLC Squamous

Pembrolizumab DRUG

Administered IV

HR+, HER2- Locally Advanced or Metastatic Breast Cancer; HR+, HER2- Metastatic Breast Cancer; NSCLC KRAS mt, PD-L1+; NSCLC Squamous

Anastrozole DRUG

Administered orally

HR+, HER2- Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (24)

Highlands Oncology Group - Duplicate 2

Springdale, Arkansas, 72762, United States

Location

Univ of California San Francisco

San Francisco, California, 94158, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute

Farmington Hills, Michigan, 48334, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman

Liège, 4000, Belgium

Location

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

Location

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault, 34090, France

Location

Hopital Larrey

Toulouse, 31059, France

Location

Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

Meldola, Forli, 47014, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Hospital Nuestra Senora de Sonsoles

Ávila, 05004, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Madrid Norte Sanchinarro

Madrid, 28050, Spain

Location

Tri-Service General Hospital

Neihu Taipei, 114, Taiwan

Location

Taipei Medical University- Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Chi Mei Hospital - Liouying Branch

Tainan, 73657, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

Istanbul, 34098, Turkey (Türkiye)

Location

Ege Universitesi Hastanesi

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Pujol JL, Vansteenkiste J, Paz-Ares Rodriguez L, Gregorc V, Mazieres J, Awad M, Janne PA, Chisamore M, Hossain AM, Chen Y, Beck JT. Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. JTO Clin Res Rep. 2021 Sep 25;2(11):100234. doi: 10.1016/j.jtocrr.2021.100234. eCollection 2021 Nov.

  PMID: 34746886 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Interventions

abemaciclib; pembrolizumab; Anastrozole

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 20, 2016
• Study Start: November 14, 2016
• Primary Completion: February 3, 2020
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (7); BE (2); IT (2); ES (4); TW (4); FR (3); TU (2)