A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)
6 de setembro de 2019 atualizado por: Eli Lilly and Company
A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
111
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Heidelberg, Alemanha, 69126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ulm, Alemanha, 89081
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Aalst, Bélgica, 9300
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Gent, Bélgica, 9000
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Mechelen, Bélgica, 2800
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Roeselare, Bélgica, 8800
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Badalona, Espanha, 08916
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Pamplona, Espanha, 31008
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Valencia, Espanha, 46026
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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California
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La Jolla, California, Estados Unidos, 92037
- University of California - San Diego
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Los Angeles, California, Estados Unidos, 90048
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Sacramento, California, Estados Unidos, 95817
- University of California, Davis - Health Systems
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Santa Monica, California, Estados Unidos, 90404
- UCLA
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Health Sciences Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Georgetown University Medical Center IRB
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Florida
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Fort Myers, Florida, Estados Unidos, 33916-2233
- Florida Cancer Specialists
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Saint Petersburg, Florida, Estados Unidos, 33705
- Florida Cancer Specialists
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Tampa, Florida, Estados Unidos, 33612
- H Lee Moffitt Cancer Center
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Georgia
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Athens, Georgia, Estados Unidos, 30607
- Northeast Georgia Cancer Care, LLC
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospital
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Kansas
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University Medical Center
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Montana
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Billings, Montana, Estados Unidos, 59101
- Billings Clinic Research Center
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Carolinas Medical Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Oncology Hematology Care Inc
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Portland VA Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37404
- Tennessee Oncology PLLC
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Memphis, Tennessee, Estados Unidos, 38120
- The West Clinic
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Nashville, Tennessee, Estados Unidos, 37203
- Tennessee Oncology PLLC
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Washington
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Kirkland, Washington, Estados Unidos, 98034
- MS Center at Evergreen
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Seattle, Washington, Estados Unidos, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Estados Unidos, 98112
- Group Health
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Tacoma, Washington, Estados Unidos, 98405
- MultiCare Health System
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Montpellier, França, 34295
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toulouse, França, 31059
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Amsterdam, Holanda, 1081 HV
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Breda, Holanda, 4818 CK
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Beer Sheva, Israel, 84101
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
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Petah Tikva, Israel, 49100
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Tel Hashomer, Israel, 52621
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Zerifin, Israel, 6093000
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Milano, Itália, 20052
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Orbassano, Itália, 10043
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Avon
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Bristol, Avon, Reino Unido, BS10 5NB
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greater London
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London, Greater London, Reino Unido, W6 8RF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hants
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Southampton, Hants, Reino Unido, SO16 6YD
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manchester
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Wythenshawe, Manchester, Reino Unido, M23 9LT
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oxford
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Headington, Oxford, Reino Unido, OX3 7LE
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul, Republica da Coréia, 138-736
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Diagnosis of metastatic Stage IV NSCLC
- At least 1 measurable extra-central nervous system (CNS) lesion
- Documented radiographic progression while on continuous treatment with erlotinib monotherapy
- Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
- Determined to be MET diagnostic positive (+)
- Availability of a tumor sample post-erlotinib progression
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Have adequate organ function
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
- Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
- Have a serious concomitant systemic disorder or significant cardiac disease
- Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
- Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
- Have major surgery less than 2 weeks prior initiation of study treatment therapy
- Pregnant or lactating women
- Have symptomatic CNS metastasis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Arm A: Emibetuzumab plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
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Administered IV
Outros nomes:
Administrado por via oral
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Experimental: Arm B: Emibetuzumab
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
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Administered IV
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Prazo: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
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ORR is confirmed best overall tumor response of CR or PR.
According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.
Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
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Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Progression Free Survival (PFS)
Prazo: Baseline to Objective Disease Progression or Death (Up to 24 Months)
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PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment. |
Baseline to Objective Disease Progression or Death (Up to 24 Months)
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Time to Progressive Disease
Prazo: Baseline to Objective Disease Progression (Up to 24 Months)
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Baseline to Objective Disease Progression (Up to 24 Months)
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Change in Tumor Size (CTS)
Prazo: Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
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Zero participants analyzed.
CTS data was not collected for analysis due to N=0 CR and N=3 PR.
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Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
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Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
Prazo: Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
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Participants achieved disease control if they had a best overall response of PR, CR or SD.
According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter.
SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.
The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.
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Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
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Duration of Response (DoR)
Prazo: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
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Zero participants analyzed.
Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
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Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
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Overall Survival (OS)
Prazo: Baseline to Death Due to Any Cause (Up to 24 Months)
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OS was defined as duration from the date of study enrollment to the date of death from any cause.
Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact.
The last contact for participants in post-discontinuation was the last date participant was known to be alive.
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Baseline to Death Due to Any Cause (Up to 24 Months)
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Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Prazo: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties.
A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines.
For functional domains and global health status, higher scores represent a better level of functioning.
For symptoms scales, higher scores represented a greater degree of symptoms.
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Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Prazo: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines.
The higher scores represent a greater degree of symptoms.
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Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
Prazo: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status. Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state). |
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
Prazo: Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
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AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.
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Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
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Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
Prazo: Baseline through 30-Day Follow-Up (Up to 24 Months)
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Baseline through 30-Day Follow-Up (Up to 24 Months)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2013
Conclusão Primária (Real)
1 de fevereiro de 2015
Conclusão do estudo (Real)
1 de março de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de julho de 2013
Primeira postagem (Estimativa)
16 de julho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de proteína quinase
- Cloridrato De Erlotinibe
Outros números de identificação do estudo
- 14208
- I4C-MC-JTBC (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Relatório de Estudo Clínico (CSR)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .