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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152631
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Results First Posted : December 12, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Abemaciclib Drug: Erlotinib Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy
Actual Study Start Date : October 3, 2014
Actual Primary Completion Date : September 15, 2017
Estimated Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Abemaciclib
200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Active Comparator: Erlotinib
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Drug: Erlotinib
Administered orally




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From Randomization Date to Date of Death from Any Cause (Up to 32 Months) ]
    OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.


Secondary Outcome Measures :
  1. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [ Time Frame: From Randomization Date to Objective Progression (Up to 32 Months) ]
    ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

  2. Progression Free Survival (PFS) [ Time Frame: From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months) ]
    PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

  3. Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score [ Time Frame: From Randomization Date through End of Study (Up to 32 Months) ]
    The MDASI-LC included 22 items + 3 additional trial-specific items, resulting in 6 collected and reported single-construct scores including core symptoms (13-item), interference (6-item), lung cancer (3-item), and trial-specific single outcomes for headache, diarrhea, and rash. A 2-construct composite core + lung cancer symptom (16-item) score was calculated. Data for all 7 scores were collected by an 11-point numeric rating scale anchored at 0 (not present or does not interfere) and 10 (as bad as you can imagine or interfered completely). The measurement range was 10 (maximum score-minimum score). Mixed Model Repeated Measure (MMRM) regression with covariates for treatment, visit, treatment*visit, and baseline score predicted between-group Least Squares (LS) mean differences from baseline. Group-level negative change from baseline indicated group improvement.

  4. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State [ Time Frame: Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles) ]
    PK is determined by the area under the plasma concentration versus time curve during 1 dosing interval at steady state

  5. Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score [ Time Frame: From Randomization Date through End of Study (Up to 32 Months) ]
    There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to. The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using United Kingdom (UK) weights, health dimensions(mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) into a single index value; the dimensions are not separately scored. The index is marked missing when ≥1 dimensions are missing. The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death. The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

  6. Resource Utilization: Percentage of Participants Who Are Hospitalized [ Time Frame: From Randomization Date through End of Study (Up to 32 Months) ]
    Resource utilization is the percentage of participants who was hospitalized.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook.
  • Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study central laboratory. A KRAS positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per local laboratory will be permitted in no more than 10% of randomized participants.
  • Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible.
  • Have measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.

Exclusion Criteria:

  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
  • Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging [MRI]) within 28 days of randomization to document stability, even if there have been no changes in symptoms.
  • Have previously completed or withdrawn from this study or any other study investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6) inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152631


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Locations
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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
City of Hope National Medical Center
Duarte, California, United States, 91010
St Jude Medical Center
Fullerton, California, United States, 92835
University of California - San Diego
La Jolla, California, United States, 92037
Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
SMO TRIO -Translational Research
Los Angeles, California, United States, 90024
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, United States, 90095
Cancer Care Associates
Redondo Beach, California, United States, 90277
Dignity Health Care Institute
Sacramento, California, United States, 95816
Central Coast Medical Oncology Corporation
Santa Monica, California, United States, 93454
United States, Colorado
SMO Catholic Health Initiatives
Englewood, Colorado, United States, 80112
United States, Delaware
Medical Oncology Hematology Consultants
Newark, Delaware, United States, 19713
United States, Florida
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton, Florida, United States, 33486
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Memorial Cancer Institute
Pembroke Pines, Florida, United States, 33028
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
Harbin Clinic
Rome, Georgia, United States, 30165
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Fort Wayne Oncology & Hematology
Fort Wayne, Indiana, United States, 46845
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67214
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
St Joseph Cancer Center
Lexington, Kentucky, United States, 40509
University of Louisville
Louisville, Kentucky, United States, 40202
Jewish Hospital
Louisville, Kentucky, United States, 40245
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Metro-West and Greater Boston CNS Research
Framingham, Massachusetts, United States, 01701
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Freeman Cancer Institute
Joplin, Missouri, United States, 64804
Mercy Medical Research Institute
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic Research Center
Billings, Montana, United States, 59101
United States, Nebraska
St. Francis Medical Center
Grand Island, Nebraska, United States, 68802
Alegent Immanuel Cancer Center
Omaha, Nebraska, United States, 68122
Oncology Hematology West
Omaha, Nebraska, United States, 68130
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Broome Oncology
Johnson City, New York, United States, 13790
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Providence Cancer Center Oncology Hematology Care
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29401
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Columbia Basin Hematology & Oncology
Kennewick, Washington, United States, 99336
Swedish Medical Center
Seattle, Washington, United States, 98104
Cancer Care Northwest
Valley, Washington, United States, 99216
Argentina
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Berazategui, Argentina, B1884BBF
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Ciudad Autonoma Buenos Aires, Argentina, 1025
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Ciudad Autonoma Buenos Aires, Argentina, 1093
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Ciudad Autonoma Buenos Aires, Argentina, C1181AAX
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Rosario, Argentina, 2000
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Rosario, Argentina, S2000DSV
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Viedma, Argentina, 8500
Austria
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Graz, Austria, 8036
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Linz, Austria, 4020
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Linz, Austria, 4021
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Salzburg, Austria, 5020
Brazil
Associação Hospital de Caridade Ijuí
Ijui, Brazil, 98700 000
Hospital Bruno Born
Lajeados, Brazil, 95900-000
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Porto Alegre, Brazil, 90610-970
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Rio De Janeiro, Brazil, 20231-050
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Salvador, Brazil, 41253-190
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Sao Jose Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 01246000
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo, Brazil, 01509-010
Canada
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Calgary, Canada, T2N 4N2
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Edmonton, Canada, T6G 1Z2
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Montreal, Canada, H2L 4M1
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Toronto, Canada, M4N 3M5
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Vancouver, Canada, V5Z 4E6
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Winnipeg, Canada, R3A 1M3
China
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Beijing, China, 100021
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Beijing, China, 100071
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Beijing, China, 100730
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Changchun, China, 130012
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Changzhou, China, 213000
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Chengdu, China, 610041
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Haikou, China, 570311
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Hang Zhou, China, 310022
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Hefei, China, 230001
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Nanning, China, 530021
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Shanghai, China, 200030
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Shenyang, China, 100042
France
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Bron, France, 69677
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Dijon, France, 21034
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Grenoble, France, 38043
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Lille, France, 59037
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Marseille, France, 13015
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Poitiers, France, 86021
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Rennes, France, 35033
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Saint-Brieuc, France, 22027
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St Priest en Jarez, France, 42270
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Toulouse, France, 31059
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Vantoux, France, 57070
Germany
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Berlin, Germany, 14165
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Gera, Germany, 07548
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Großhansdorf, Germany, 22927
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Hamburg, Germany, 21075
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Hannover, Germany, 30459
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Heidelberg, Germany, 69126
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Immenhausen, Germany, 34376
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Nürnberg, Germany, 90419
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Regensburg, Germany, 93053
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Rosenheim, Germany, 83022
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Tübingen, Germany, 72076
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Ulm, Germany, 89081
Greece
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Athens, Greece, 11522
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Athens, Greece, 11527
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Athens, Greece, 18537
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Heraklion, Greece, 71110
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Patras, Greece, 26504
Israel
Soroka Medical Center
Beer Sheva, Israel, 8410101
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Holon, Israel, 5822012
Hadassah Medical Center - Ein Karem
Jerusalem, Israel, 9112001
Meir Medical Center
Kfar Saba, Israel, 4428164
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Petah Tiqva, Israel, 4941492
Sheba Medical Center
Tel Hashomer, Israel, 5265601
Italy
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Catania, Italy, 95125
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Genova, Italy, 16132
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Livorno, Italy, 57124
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Parma, Italy, 43100
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Rome, Italy, 00152
Japan
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Amagasaki, Japan, 660-0892
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Asahikawa, Japan, 070-8644
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Bunkyo-ku, Japan, 113-8431
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Bunkyo-Ku, Japan, 113-8677
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Fukuoka, Japan, 811-1395
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Habikino, Japan, 583-8588
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Hirakata, Japan, 573-1191
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Hiroshima, Japan, 734-8551
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Hyogo, Japan, 6608550
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Kanazawa, Japan, 920-8641
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Kashiwa, Japan, 277 8577
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Kishiwada, Japan, 596-8501
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Kitaadachi-Gun, Japan, 362-0806
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Kobe, Japan, 650-0047
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Koto-ku, Japan, 135-8550
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Kurashiki, Japan, 710-8602
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Matsuyama, Japan, 791-0280
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Nagasaki, Japan, 852-8501
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Nagoya, Japan, 464-8681
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Nagoya, Japan, 466-8560
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Natori, Japan, 981-1293
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Okayama, Japan, 700-8558
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Osakasayama, Japan, 589-8511
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Osaka, Japan, 534-0021
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Osaka, Japan, 537-8511
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Osaka, Japan, 545-8586
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Sakai, Japan, 5918555
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Sendai, Japan, 980-0873
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Shinjuku-ku, Japan, 160-0023
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Sunto-Gun, Japan, 411-8777
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Ube, Japan, 755-0241
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Utsunomiya, Japan, 320-0834
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Wakayama, Japan, 641-8510
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Yokohama, Japan, 236-0004
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Yonago, Japan, 683-0826
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Yufu-shi, Japan, 8795593
Korea, Republic of
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Goyang-Si, Korea, Republic of, 10408
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Incheon, Korea, Republic of, 21565
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 06591
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Seowon-Gu, Korea, Republic of, 28644
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Suwon, Korea, Republic of, 16247
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Ulsan-si, Korea, Republic of, 44033
Poland
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Gdansk, Poland, 80-219
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Lodz, Poland, 90-242
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Olsztyn, Poland, 10-357
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Radom, Poland, 26-617
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Szczecin, Poland, 70-891
Puerto Rico
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921-3201
Romania
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Baia Mare, Romania, 430031
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Bucharest, Romania, 022328
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Cluj-Napoca, Romania, 400015
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Cluj-Napoca, Romania, 400058
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Craiova, Romania, 200347
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Private clinic "Evimed"
Chelyabinsk, Russian Federation, 454048
Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
Krasnodar, Russian Federation, 350086
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Kursk, Russian Federation, 305035
Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
Moscow, Russian Federation, 115478
St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Russian Federation, 197758
Saint-Petersburg city clinical oncology dispensary
Saint Petersburg, Russian Federation, 198255
Republic clinical oncology dispensary of MoH of Bashkortostan Republic
Ufa, Russian Federation, 450054
Volgograd regional clinical oncology dispensary
Volzhskiy, Russian Federation, 404130
Spain
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Barcelona, Spain, 08003
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L'Hospitalet de Llobregat, Spain, 08907
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La Coruña, Spain, 15006
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Madrid, Spain, 28040
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Madrid, Spain, 28041
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Madrid, Spain, 28050
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Malaga, Spain, 29010
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Sevilla, Spain, 41013
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Valencia, Spain, 46026
Taiwan
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Chiayi, Taiwan, 613
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Jhonghe City, Taiwan, 235
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Kaohsiung City, Taiwan, 82445
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Kaohsiung, Taiwan, 83301
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Taichung City, Taiwan, 404
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 10449
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Taipei, Taiwan, 11217
Turkey
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Ankara, Turkey, 06100
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Ankara, Turkey, 06490
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Antalya, Turkey, 07059
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Edirne, Turkey, 22030
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Istanbul, Turkey, 34020
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Istanbul, Turkey, 34098
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Istanbul, Turkey, 34890
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Izmir, Turkey, 35100
Ukraine
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Dnipropetrovsk, Ukraine, 49102
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Kharkiv, Ukraine, 61070
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Kriviy Rig, Ukraine, 50048
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Kyiv, Ukraine, 04107
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Lutsk, Ukraine, 63000
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Poltava, Ukraine, 36011
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Sumy, Ukraine, 40005
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Uzhhorod, Ukraine, 88000
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Vinnitsa, Ukraine, 21029
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Statistical Analysis Plan  [PDF] October 2, 2017
Study Protocol: Protocol  [PDF] May 13, 2014
Study Protocol: Protocol (e)  [PDF] December 20, 2016


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02152631     History of Changes
Other Study ID Numbers: 15296
I3Y-MC-JPBK ( Other Identifier: Eli Lilly and Company )
2013-004662-33 ( EudraCT Number )
First Posted: June 2, 2014    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
Therapy, Platinum, Kras +
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action