Active Not RecruitingPhase 1NCT02779751
Official study titleA Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
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.
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Key things to know
Main goalTreatment
This describes the study’s primary purpose.
What is being studiedAbemaciclib and Pembrolizumab
Plus 1 other study approaches.
Who it may be forNon-small cell lung cancer (NSCLC) · HER2
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 26, 2026 · Source: ClinicalTrials.gov
Is enrollment open?Active Not Recruiting
The study is underway but is not accepting new participants.
What kind of study?Phase 1
Interventional
Where is it offered?24 U.S. locations
Locations may change over time.
Who runs it?Eli Lilly and Company
Study sponsor
Study overview
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Abemaciclib; Drug: Pembrolizumab; Drug: Anastrozole
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How this study is categorized
These labels come from structured fields and exact terms in the public record.
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- Highlands Oncology Group - Duplicate 2Springdale, Arkansas
- Univ of California San FranciscoSan Francisco, California
- University of Colorado School of MedicineAurora, Colorado
- Dana Farber Cancer InstituteBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
- Karmanos Cancer InstituteFarmington Hills, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuven
- Centre Hospitalier Universitaire Sart TilmanLiège
- Centre Oscar LambretLille, Hauts-de-France
- Hôpital Arnaud de Villeneuve - CHU MontpellierMontpellier, Hérault
- Hopital LarreyToulouse
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 26, 2026. Always confirm current availability with the study team.