- 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); or Part C: metastatic
breast cancer (HR+, HER2-).
- Part A: must be chemotherapy nave 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
- 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)
- Have discontinued all previous treatments for cancer and recovered from the acute
effects of therapy.
- Have an estimated life expectancy of 12 weeks.
- 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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease
Duration of Response (DoR)
Progression Free Survival (PFS)
Overall Survival (OS)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
PK: Mean Steady State Exposure of Pembrolizumab
Change from Baseline on the MD Anderson Symptom Inventory (MDASI)