Active, not recruiting
Phase 1
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
Condition(s) studied
Non Small Cell Lung CancerBreast Cancer
Investigational drug(s) / intervention(s)
Abemaciclib: Administered orally
Pembrolizumab: Administered IV
Anastrozole: Administered orally
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) — Baseline through Study Treatment Completion (Approximately 6 Months)
- Number of Participants with Non-Serious Adverse Event(s) — Baseline through Study Treatment Completion (Approximately 6 Months)
Trial sites (24)
| Facility | City | Region | Status |
| Highlands Oncology Group - Duplicate 2 |
Springdale |
Arkansas |
|
| Univ of California San Francisco |
San Francisco |
California |
|
| University of Colorado School of Medicine |
Aurora |
Colorado |
|
| Dana Farber Cancer Institute |
Boston |
Massachusetts |
|
| Karmanos Cancer Institute |
Detroit |
Michigan |
|
| Karmanos Cancer Institute |
Farmington Hills |
Michigan |
|
| Memorial Sloan Kettering Cancer Center |
New York |
New York |
|
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg |
Leuven |
Belgium |
|
| Centre Hospitalier Universitaire Sart Tilman |
Liège |
Belgium |
|
| Centre Oscar Lambret |
Lille |
Hauts-de-France |
|
| Hôpital Arnaud de Villeneuve - CHU Montpellier |
Montpellier |
Hérault |
|
| Hopital Larrey |
Toulouse |
France |
|
| Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori |
Meldola |
Forli |
|
| IRCCS Ospedale San Raffaele |
Milan |
Italy |
|
| Hospital Nuestra Senora de Sonsoles |
Ávila |
Spain |
|
| Hospital San Pedro de Alcantara |
Cáceres |
Spain |
|
| Hospital Universitario 12 de Octubre |
Madrid |
Spain |
|
| Hospital Madrid Norte Sanchinarro |
Madrid |
Spain |
|
| Tri-Service General Hospital |
Neihu Taipei |
Taiwan |
|
| Taipei Medical University- Shuang Ho Hospital |
New Taipei City |
Taiwan |
|
| Chi Mei Hospital - Liouying Branch |
Tainan |
Taiwan |
|
| National Taiwan University Hospital |
Taipei |
Taiwan |
|
| Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi |
Istanbul |
Turkey (Türkiye) |
|
| Ege Universitesi Hastanesi |
Izmir |
Turkey (Türkiye) |
|
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