Clinical Trials List
Protocol NumberI3Y-MC-JPCE
NCT Number(ClinicalTrials.gov Identfier)NCT02779751
Completed
2016-06-01 - 2019-12-31
Phase I
Terminated4
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
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
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳宇欽 Division of Hematology & Oncology
- 張平穎 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 彭萬誠 Division of Thoracic Medicine
- 黃子權 Division of Hematology & Oncology
- 沈志浩 Division of Thoracic Medicine
- 蔡鎮良 Division of Thoracic Medicine
- 陳佳宏 Division of Hematology & Oncology
- 戴明燊 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蘇勇誠 Division of Hematology & Oncology
- Wei-Hwa Lee Division of Others -
- Wei-Hong Cheng Division of Hematology & Oncology
- Tsu-Yi Chao Division of Hematology & Oncology
- kang-Yun LEE Division of Thoracic Medicine
- Yao-Yu Hsieh Division of Hematology & Oncology
- Po-Hao Feng Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Co-Principal Investigator
- Chong-Jen Yu Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- 張端瑩 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- YEN-SHEN LU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
Objectives
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.
Test Drug
1. Abemaciclib 2. Pembrolizumab
Active Ingredient
Abemaciclib (LY2835219)
Pembrolizumab
Pembrolizumab
Dosage Form
Capsule
Injection
Injection
Dosage
50
50
50
Endpoints
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) ]
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) ]
Inclution 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-)
o Part A: must be chemotherapy naïve for metastatic NSCLC
o Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC
o Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
o 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.
• 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-)
o Part A: must be chemotherapy naïve for metastatic NSCLC
o Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC
o Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
o 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
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:
o Have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to Cycle 1 Day 1.
o 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.
o 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.
• 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:
o Have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to Cycle 1 Day 1.
o 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.
o 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.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
75 participants
