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



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:November 14, 2016
End Date:October 29, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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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

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.


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.
We found this trial at
7
sites
Detroit, Michigan 48201
Principal Investigator: Anmar Sukari
Phone: 313-576-8753
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Aurora, Colorado 80045
Principal Investigator: Peter Kabos
Phone: 720-848-1032
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Sara M Tolaney
Phone: 617-632-3800
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph T Beck
Phone: 479-587-1700
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Leuven, 3001
Principal Investigator: Hans Wildiers
Phone: 3216346900
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Leuven,
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Komal Jhaveri
Phone: 646-888-5145
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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San Francisco, California 94143
Principal Investigator: Hope Rugo
Phone: 415-353-7618
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San Francisco, CA
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