A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Eli Lilly and Company
Study ID
NCT02152631
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Administered orally
  • Erlotinib — DRUG
    Administered orally

Study Details

The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.

Key Dates

First listed
Jun 2, 2014
Start date
Oct 3, 2014
Status verified
Jan 2026
Primary completion
Sep 15, 2017
Completion
Dec 31, 2026

Study Design

Enrollment
453 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Abemaciclib
    200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).
  • Active Comparator: Erlotinib
    150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From Randomization Date to Date of Death from Any Cause (Up to 32 Months) ]

Locations (54)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
St. Bernards Medical CenterJonesboroArkansas72401-
City of Hope National Medical CenterDuarteCalifornia91010-
University of California - San DiegoLa JollaCalifornia92037-
Loma Linda University School of MedicineLoma LindaCalifornia92350-
Cancer Care Associates Medical GroupLos AngelesCalifornia90095-
CBCC Global Research, Inc.Los AngelesCalifornia90024-
Central Coast Medical Oncology CorporationLos AngelesCalifornia90024-
Fort Wayne Oncology & HematologyLos AngelesCalifornia90024-
SMO TRIO -Translational ResearchLos AngelesCalifornia90024-
St. Joseph Heritage Medical GroupLos AngelesCalifornia90024-
UCLA Department of Medicine-Hematology/OncologyLos AngelesCalifornia90024-
Dignity Health Care InstituteSacramentoCalifornia95816-
Alegent Immanuel Cancer CenterEnglewoodColorado80112-
Jewish HospitalEnglewoodColorado80112-
Oncology Hematology WestEnglewoodColorado80112-
SMO Catholic Health InitiativesEnglewoodColorado80112-
St Joseph Cancer CenterEnglewoodColorado80112-
St. Francis Medical CenterEnglewoodColorado80112-
Medical Oncology Hematology ConsultantsNewarkDelaware19713-
Boca Raton Regional HospitalBoca RatonFlorida33486-
Halifax Medical CenterDaytona BeachFlorida32114-
Memorial Cancer InstitutePembroke PinesFlorida33028-
H Lee Moffitt Cancer CenterTampaFlorida33612-9497-
University Cancer & Blood Center, LLCAthensGeorgia30607-
Ingalls Memorial HospitalHarveyIllinois60426-
Indiana University School of MedicineIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
Cancer Center of Kansas, P.A.WichitaKansas67214-
Central Baptist HospitalLexingtonKentucky40503-
University of LouisvilleLouisvilleKentucky40202-
Walter Reed National Military Medical CenterBethesdaMaryland20889-
Metro-West and Greater Boston CNS ResearchFraminghamMassachusetts01701-
Karmanos Cancer InstituteDetroitMichigan48201-
Mercy Medical Research InstituteSpringfieldMissouri65807-
Billings Clinic Research CenterBillingsMontana59101-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Broome OncologyJohnson CityNew York13790-
Weill Cornell Medical CollegeNew YorkNew York10065-
Oncology Hematology Care IncCincinnatiOhio45242-
Oklahoma Cancer Specialists & Research Institute, LLCTulsaOklahoma74146-
Providence Cancer Center Oncology Hematology CarePortlandOregon97213-
UPMC Hillman Cancer CenterPittsburghPennsylvania15213-
Roper St. Francis HealthcareCharlestonSouth Carolina29401-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Chattanooga Oncology Hematology AssociatesNashvilleTennessee37203-
Tennessee Oncology PLLCNashvilleTennessee37203-
Mary Crowley Cancer Research CenterDallasTexas75230-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
University of Vermont Medical CenterBurlingtonVermont05401-
Virginia Commonwealth UniversityRichmondVirginia23298-
Kadlec Clinical Hematology & OncologyKennewickWashington99336-
Swedish Medical CenterSeattleWashington98104-
Cancer Care NorthwestValleyWashington99216-

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