A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
NCT ID: NCT02779751
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2016-11-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Abemaciclib
Administered orally
Pembrolizumab
Administered IV
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.
Abemaciclib
Administered orally
Pembrolizumab
Administered IV
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.
Abemaciclib
Administered orally
Pembrolizumab
Administered IV
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.
Abemaciclib
Administered orally
Pembrolizumab
Administered IV
Anastrozole
Administered orally
Interventions
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Abemaciclib
Administered orally
Pembrolizumab
Administered IV
Anastrozole
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Highlands Oncology Group - Duplicate 2
Springdale, Arkansas, United States
Univ of California San Francisco
San Francisco, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, , Belgium
Centre Oscar Lambret
Lille, Hauts-de-France, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, France
Hopital Larrey
Toulouse, , France
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
Meldola, Forli, Italy
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)
Countries
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References
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Pujol JL, Vansteenkiste J, Paz-Ares Rodriguez L, Gregorc V, Mazieres J, Awad M, Janne PA, Chisamore M, Hossain AM, Chen Y, Beck JT. Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. JTO Clin Res Rep. 2021 Sep 25;2(11):100234. doi: 10.1016/j.jtocrr.2021.100234. eCollection 2021 Nov.
Related Links
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A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
Other Identifiers
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I3Y-MC-JPCE
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005156-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE 287
Identifier Type: OTHER
Identifier Source: secondary_id
16177
Identifier Type: -
Identifier Source: org_study_id
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