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Trial record 1 of 1 for:    "NCT02779751"
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A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Eli Lilly and Company
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02779751
First received: May 19, 2016
Last updated: July 13, 2017
Last verified: July 2017
  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.

Condition Intervention Phase
Non Small Cell Lung Cancer Breast Cancer Drug: Abemaciclib Drug: Pembrolizumab Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR): 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): 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) [ 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) [ 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 [ Time Frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles) ]
  • PK: Mean Steady State Exposure of Pembrolizumab [ Time Frame: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles) ]
  • Change from Baseline on the MD Anderson Symptom Inventory (MDASI) [ Time Frame: Baseline, End of Study (Approximately 6 Months) ]

Estimated Enrollment: 75
Actual Study Start Date: November 14, 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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); or Part C: 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
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 )
Study First Received: May 19, 2016
Last Updated: July 13, 2017

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
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 19, 2017