Clinical Trials /

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

NCT02779751

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Abemaciclib</span> (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

Title

  • Brief Title: A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
  • Official Title: A Phase 2 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
  • Clinical Trial IDs

    NCT ID: NCT02779751

    ORG ID: 16177

    NCI ID: I3Y-MC-JPCE

    Trial Conditions

    Non Small Cell Lung Cancer

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Abemaciclib LY2835219 NSCLC KRAS mt, PD-L1+, NSCLC Squamous, HR+, HER2- Metastatic Breast Cancer
    Pembrolizumab NSCLC KRAS mt, PD-L1+, NSCLC Squamous, HR+, HER2- Metastatic Breast Cancer

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    NSCLC KRAS mt, PD-L1+ Experimental Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Abemaciclib, Pembrolizumab
    NSCLC Squamous Experimental Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Abemaciclib, Pembrolizumab
    HR+, HER2- Metastatic Breast Cancer Experimental Abemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Abemaciclib, Pembrolizumab

    Eligibility Criteria

    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); 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)
    scale.

    - Have discontinued all previous treatments for cancer and recovered from the acute
    effects of therapy.

    - Have an estimated life expectancy of 12 weeks.

    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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of Participants with One or More Serious Adverse Event(s) (SAEs)

    Number of Participants with Non-Serious Adverse Event(s)

    Secondary Outcome Measures

    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)

    Trial Keywords