Breast Cancer or NSCLC

CDK4 & 6 Inhibitor

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*

show modal icon NCT02779751
Key Inclusion Criteria
  • Stage IV non-small cell lung cancer (NSCLC) or hormone-receptor-positive (HR+), HER2-negative breast cancer
  • Part A: Chemotherapy-naïve, KRAS-mutant, PD-L1-positive NSCLC
  • Part B: Squamous NSCLC. Participants must have received only one prior platinum-based chemotherapy for advanced/metastatic NSCLC
  • Part C: HR+, HER2-negative breast cancer. Participants must have received at least one, but no more than two, chemotherapy regimens in the metastatic setting
  • Part D: Locally advanced or metastatic HR+, HER2-negative breast cancer
  • Willing to provide tumor tissue prior to treatment and after treatment initiation
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must agree to use highly effective methods of contraception during the study and for 120 days following last dose of study drug
  • Discontinued all previous treatments for cancer and recovered from the acute effects of therapy
  • Life expectancy of ≥12 weeks
Key Exclusion Criteria
  • Part D: Currently receiving or previously received endocrine therapy OR chemotherapy for locoregionally recurrent or metastatic breast cancer. Initiated bisphosphonates or approved RANK-ligand (RANK-L) targeted agents <7 days prior to cycle 1 day 1
  • History of syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • Central nervous system metastasis with development of associated neurological changes 14 days prior to receiving study drug
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast) unless in complete remission with no therapy for a minimum of 3 years
  • Pregnant, breastfeeding, or expecting to conceive or father children within the duration of the trial through 4 months after last dose of trial treatment
  • QTc interval >470 ms on electrocardiogram
  • History of interstitial lung disease
  • History of or active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years
  • Prior anti-PD-1, anti-PD-L1, or anti-CTLA4 agent
  • Prior therapy with a CDK4 & 6 inhibitor
  • Active bacterial, fungal, and/or known viral infection
This clinical trial is being conducted globally in partnership with Merck Sharp & Dohme Corp. 
Abemaciclib is administered PO Q12H on days 1-21 of each 21-day cycle.
Pembrolizumab is administered intravenously on day 1 of each 21-day cycle.
Anastrozole is administered PO Q24H on days 1-21 of each 21-day cycle.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.