A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)
2019년 9월 6일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
111
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드, 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, 네덜란드, 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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Seoul, 대한민국, 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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Heidelberg, 독일, 69126
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Ulm, 독일, 89081
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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California
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La Jolla, California, 미국, 92037
- University of California - San Diego
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Los Angeles, California, 미국, 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, 미국, 95817
- University of California, Davis - Health Systems
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Santa Monica, California, 미국, 90404
- UCLA
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Health Sciences Center
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- Georgetown University Medical Center IRB
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Florida
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Fort Myers, Florida, 미국, 33916-2233
- Florida Cancer Specialists
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Saint Petersburg, Florida, 미국, 33705
- Florida Cancer Specialists
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Tampa, Florida, 미국, 33612
- H Lee Moffitt Cancer Center
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Georgia
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Athens, Georgia, 미국, 30607
- Northeast Georgia Cancer Care, LLC
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Atlanta, Georgia, 미국, 30322
- Emory University
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospital
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Kansas
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Westwood, Kansas, 미국, 66205
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, 미국, 48201
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University Medical Center
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Montana
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Billings, Montana, 미국, 59101
- Billings Clinic Research Center
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth Hitchcock Medical Center
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New York
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New York, New York, 미국, 10032
- Columbia University
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Carolinas Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care Inc
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Oregon
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Portland, Oregon, 미국, 97213
- Portland VA Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Tennessee Oncology PLLC
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Memphis, Tennessee, 미국, 38120
- The West Clinic
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology PLLC
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Washington
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Kirkland, Washington, 미국, 98034
- MS Center at Evergreen
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Seattle, Washington, 미국, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, 미국, 98112
- Group Health
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Tacoma, Washington, 미국, 98405
- MultiCare Health System
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Aalst, 벨기에, 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, 벨기에, 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, 벨기에, 2800
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Roeselare, 벨기에, 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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Badalona, 스페인, 08916
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Pamplona, 스페인, 31008
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Valencia, 스페인, 46026
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Avon
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Bristol, Avon, 영국, 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, 영국, 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, 영국, 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, 영국, 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, 영국, 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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Beer Sheva, 이스라엘, 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, 이스라엘, 91120
- 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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Kfar Saba, 이스라엘, 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, 이스라엘, 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, 이스라엘, 52621
- 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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Zerifin, 이스라엘, 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, 이탈리아, 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, 이탈리아, 10043
- 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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Montpellier, 프랑스, 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, 프랑스, 31059
- 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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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
경구 투여
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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression Free Survival (PFS)
기간: 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
기간: 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)
기간: 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)]
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 8월 1일
기본 완료 (실제)
2015년 2월 1일
연구 완료 (실제)
2016년 3월 1일
연구 등록 날짜
최초 제출
2013년 7월 12일
QC 기준을 충족하는 최초 제출
2013년 7월 12일
처음 게시됨 (추정)
2013년 7월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 6일
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 14208
- I4C-MC-JTBC (기타 식별자: Eli Lilly and Company)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 임상 연구 보고서(CSR)
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