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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Administered orally
Administered IV
Administered orally
Highlands Oncology Group - Duplicate 2
Springdale, Arkansas, United States
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Time frame: Baseline through Study Treatment Completion (Approximately 6 Months)
Number of Participants with Non-Serious Adverse Event(s)
Time frame: Baseline through Study Treatment Completion (Approximately 6 Months)
Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response
Time frame: 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
Time frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Duration of Response (DoR) per RECIST v1.1
Time frame: 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
Time frame: Baseline to Measured Progressive Disease or Death (Approximately 10 Months)
Overall Survival (OS)
Time frame: Baseline to Date of Death Due to Any Cause (Approximately 18 Months)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib in Combination with Pembrolizumab with or without Anastrozole
Time frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles)
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