Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-04-09 @ 7:02 AM
Study NCT ID:
NCT02779751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000590451', 'term': 'abemaciclib'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03763604', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs)', 'timeFrame': 'Baseline through Study Treatment Completion (Approximately 6 Months)'}, {'measure': 'Number of Participants with Non-Serious Adverse Event(s)', 'timeFrame': 'Baseline through Study Treatment Completion (Approximately 6 Months)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response', 'timeFrame': 'Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)'}, {'measure': 'Disease Control Rate (DCR) per RECIST v1.1: Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease', 'timeFrame': 'Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)'}, {'measure': 'Duration of Response (DoR) per RECIST v1.1', 'timeFrame': 'Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 12 Months)'}, {'measure': 'Progression Free Survival (PFS) per RECIST v1.1', 'timeFrame': 'Baseline to Measured Progressive Disease or Death (Approximately 10 Months)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to Date of Death Due to Any Cause (Approximately 18 Months)'}, {'measure': 'Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib in Combination with Pembrolizumab with or without Anastrozole', 'timeFrame': 'Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34746886', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/7MTCU0kNXyEgCUKm0oQgIY', 'label': 'A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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-)\n\n * Part A: must be chemotherapy naïve for metastatic NSCLC\n * Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC\n * Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting\n * 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.\n* Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).\n* Have presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Have a performance status (PS) ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.\n* Have an estimated life expectancy of ≥12 weeks.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug.\n* Have corrected QT interval of \\>470 milliseconds on screening electrocardiogram (ECG).\n* Have history of interstitial lung disease or pneumonitis.\n* Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.\n* Have received a live vaccination within 30 days of study start.\n* 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.\n* For Part D Only:\n\n * Have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) \\<7 days prior to Cycle 1 Day 1.\n * 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.\n * 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.'}, 'identificationModule': {'nctId': 'NCT02779751', 'briefTitle': 'A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '16177'}, 'secondaryIdInfos': [{'id': 'I3Y-MC-JPCE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2015-005156-94', 'type': 'EUDRACT_NUMBER'}, {'id': 'KEYNOTE 287', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NSCLC KRAS mt, PD-L1+', 'description': '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.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'NSCLC Squamous', 'description': '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.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'HR+, HER2- Metastatic Breast Cancer', 'description': '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.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'HR+, HER2- Locally Advanced or Metastatic Breast Cancer', 'description': '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.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Pembrolizumab', 'Drug: Anastrozole']}], 'interventions': [{'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally', 'armGroupLabels': ['HR+, HER2- Locally Advanced or Metastatic Breast Cancer', 'HR+, HER2- Metastatic Breast Cancer', 'NSCLC KRAS mt, PD-L1+', 'NSCLC Squamous']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['HR+, HER2- Locally Advanced or Metastatic Breast Cancer', 'HR+, HER2- Metastatic Breast Cancer', 'NSCLC KRAS mt, PD-L1+', 'NSCLC Squamous']}, {'name': 'Anastrozole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['HR+, HER2- Locally Advanced or Metastatic Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group - Duplicate 2', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Univ of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '59020', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34090', 'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve - CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '47014', 'city': 'Meldola', 'state': 'Forli', 'country': 'Italy', 'facility': 'Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '05004', 'city': 'Ávila', 'country': 'Spain', 'facility': 'Hospital Nuestra Senora de Sonsoles', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}, {'zip': '10003', 'city': 'Cáceres', 'country': 'Spain', 'facility': 'Hospital San Pedro de Alcantara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Madrid Norte Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '114', 'city': 'Neihu Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital'}, {'zip': '235', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Taipei Medical University- Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '73657', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi Mei Hospital - Liouying Branch', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Universitesi Hastanesi', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': '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', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}