A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)
6 september 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
111
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Aalst, België, 9300
- 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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Gent, België, 9000
- 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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Mechelen, België, 2800
- 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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Roeselare, België, 8800
- 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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Heidelberg, Duitsland, 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, Duitsland, 89081
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Montpellier, Frankrijk, 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, Frankrijk, 31059
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Beer Sheva, Israël, 84101
- 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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Jerusalem, Israël, 91120
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Kfar Saba, Israël, 44281
- 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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Petah Tikva, Israël, 49100
- 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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Tel Hashomer, Israël, 52621
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Zerifin, Israël, 6093000
- 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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Milano, Italië, 20052
- 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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Orbassano, Italië, 10043
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Seoul, Korea, republiek van, 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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Amsterdam, Nederland, 1081 HV
- 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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Breda, Nederland, 4818 CK
- 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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Badalona, Spanje, 08916
- 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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Pamplona, Spanje, 31008
- 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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Valencia, Spanje, 46026
- 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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Avon
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Bristol, Avon, Verenigd Koninkrijk, 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, Verenigd Koninkrijk, 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, Verenigd Koninkrijk, 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, Verenigd Koninkrijk, 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, Verenigd Koninkrijk, 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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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
- University of Alabama at Birmingham
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California
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La Jolla, California, Verenigde Staten, 92037
- University of California - San Diego
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Los Angeles, California, Verenigde Staten, 90048
- 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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Sacramento, California, Verenigde Staten, 95817
- University of California, Davis - Health Systems
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Santa Monica, California, Verenigde Staten, 90404
- UCLA
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Health Sciences Center
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20007
- Georgetown University Medical Center IRB
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Florida
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Fort Myers, Florida, Verenigde Staten, 33916-2233
- Florida Cancer Specialists
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Saint Petersburg, Florida, Verenigde Staten, 33705
- Florida Cancer Specialists
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Tampa, Florida, Verenigde Staten, 33612
- H Lee Moffitt Cancer Center
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Georgia
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Athens, Georgia, Verenigde Staten, 30607
- Northeast Georgia Cancer Care, LLC
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
- University of Iowa Hospital
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Kansas
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Westwood, Kansas, Verenigde Staten, 66205
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Verenigde Staten, 48201
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 63110
- Washington University Medical Center
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Montana
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Billings, Montana, Verenigde Staten, 59101
- Billings Clinic Research Center
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Hitchcock Medical Center
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New York
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New York, New York, Verenigde Staten, 10032
- Columbia University
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
- Carolinas Medical Center
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- Oncology Hematology Care Inc
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Oregon
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Portland, Oregon, Verenigde Staten, 97213
- Portland VA Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Fox Chase Cancer Center
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Tennessee Oncology PLLC
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Memphis, Tennessee, Verenigde Staten, 38120
- The West Clinic
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Nashville, Tennessee, Verenigde Staten, 37203
- Tennessee Oncology PLLC
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Washington
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Kirkland, Washington, Verenigde Staten, 98034
- MS Center at Evergreen
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Seattle, Washington, Verenigde Staten, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Verenigde Staten, 98112
- Group Health
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Tacoma, Washington, Verenigde Staten, 98405
- MultiCare Health System
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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
Andere namen:
Oraal toegediend
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Experimenteel: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression Free Survival (PFS)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)]
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2013
Primaire voltooiing (Werkelijk)
1 februari 2015
Studie voltooiing (Werkelijk)
1 maart 2016
Studieregistratiedata
Eerst ingediend
12 juli 2013
Eerst ingediend dat voldeed aan de QC-criteria
12 juli 2013
Eerst geplaatst (Schatting)
16 juli 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 september 2019
Laatste update ingediend die voldeed aan QC-criteria
6 september 2019
Laatst geverifieerd
1 september 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Erlotinibhydrochloride
Andere studie-ID-nummers
- 14208
- I4C-MC-JTBC (Andere identificatie: Eli Lilly and Company)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Ja
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD delen Ondersteunend informatietype
- Leerprotocool
- Statistisch Analyse Plan (SAP)
- Klinisch onderzoeksrapport (CSR)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .