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Clinical Trials in the USA / NCT02779751
Active, not recruiting Phase 1

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

NCT02779751 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2016-11-14
Last updated
2026-01-26

Condition(s) studied

Non Small Cell Lung CancerBreast Cancer

Investigational drug(s) / intervention(s)

AbemaciclibPembrolizumabAnastrozole

Abemaciclib: Administered orally

Pembrolizumab: Administered IV

Anastrozole: Administered orally

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Highlands Oncology Group - Duplicate 2 Springdale Arkansas
Univ of California San Francisco San Francisco California
University of Colorado School of Medicine Aurora Colorado
Dana Farber Cancer Institute Boston Massachusetts
Karmanos Cancer Institute Detroit Michigan
Karmanos Cancer Institute Farmington Hills Michigan
Memorial Sloan Kettering Cancer Center New York New York
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
Centre Hospitalier Universitaire Sart Tilman Liège Belgium
Centre Oscar Lambret Lille Hauts-de-France
Hôpital Arnaud de Villeneuve - CHU Montpellier Montpellier Hérault
Hopital Larrey Toulouse France
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori Meldola Forli
IRCCS Ospedale San Raffaele Milan Italy
Hospital Nuestra Senora de Sonsoles Ávila Spain
Hospital San Pedro de Alcantara Cáceres Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Madrid Norte Sanchinarro Madrid Spain
Tri-Service General Hospital Neihu Taipei Taiwan
Taipei Medical University- Shuang Ho Hospital New Taipei City Taiwan
Chi Mei Hospital - Liouying Branch Tainan Taiwan
National Taiwan University Hospital Taipei Taiwan
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi Istanbul Turkey (Türkiye)
Ege Universitesi Hastanesi Izmir Turkey (Türkiye)

On this site

📄 Verzenio (abemaciclib) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02779751 on ClinicalTrials.gov ↗ ← All trials in the USA