ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02779751
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Breast Cancer Drug: Abemaciclib Drug: Pembrolizumab Drug: Anastrozole Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 14, 2016
Estimated Primary Completion Date : September 13, 2019
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NSCLC KRAS mt, PD-L1+
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.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Drug: Pembrolizumab
Administered IV

Experimental: NSCLC Squamous
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.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Drug: Pembrolizumab
Administered IV

Experimental: HR+, HER2- Metastatic Breast Cancer
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.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Drug: Pembrolizumab
Administered IV

Experimental: HR+, HER2- Locally Advanced or Metastatic Breast Cancer
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 and anastrozole given orally Q24H on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Drug: Pembrolizumab
Administered IV

Drug: Anastrozole
Administered orally




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) [ Time Frame: Baseline through Study Treatment Completion (Approximately 6 Months) ]
  2. Number of Participants with Non-Serious Adverse Event(s) [ Time Frame: Baseline through Study Treatment Completion (Approximately 6 Months) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Progression Free Survival (PFS) per RECIST v1.1 [ Time Frame: Baseline to Measured Progressive Disease or Death (Approximately 10 Months) ]
  5. Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Approximately 18 Months) ]
  6. Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [ Time Frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles) ]
  7. PK: Mean Steady State Exposure of Pembrolizumab [ Time Frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles) ]
  8. PK: Mean Steady State Exposure of Anastrozole [ Time Frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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); 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.

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779751


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 27 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Merck Sharp & Dohme Corp.
Investigators
Study Director: Call 1-877-CTILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02779751     History of Changes
Other Study ID Numbers: 16177
I3Y-MC-JPCE ( Other Identifier: Eli Lilly and Company )
2015-005156-94 ( EudraCT Number )
KEYNOTE 287 ( Other Identifier: Merck )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Anastrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs