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A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)

6. září 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

111

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Aalst, Belgie, 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.
      • Gent, Belgie, 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.
      • Mechelen, Belgie, 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.
      • Roeselare, Belgie, 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.
  • Francie
      • Montpellier, Francie, 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.
      • Toulouse, Francie, 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.
  • Holandsko
      • Amsterdam, Holandsko, 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.
      • Breda, Holandsko, 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.
  • Itálie
      • Milano, Itálie, 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.
      • Orbassano, Itálie, 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.
  • Izrael
      • Beer Sheva, Izrael, 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.
      • Jerusalem, Izrael, 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.
      • Kfar Saba, Izrael, 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.
      • Petah Tikva, Izrael, 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.
      • Tel Hashomer, Izrael, 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.
      • Zerifin, Izrael, 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.
  • Korejská republika
      • Seoul, Korejská republika, 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.
  • Německo
      • Heidelberg, Německo, 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.
      • Ulm, Německo, 89081
        • 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.
  • Spojené království
    • Avon
      • Bristol, Avon, Spojené království, 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.
    • Greater London
      • London, Greater London, Spojené království, 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.
    • Hants
      • Southampton, Hants, Spojené království, 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.
    • Manchester
      • Wythenshawe, Manchester, Spojené království, 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.
    • Oxford
      • Headington, Oxford, Spojené království, 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.
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35294
        • University of Alabama at Birmingham
    • California
      • La Jolla, California, Spojené státy, 92037
        • University of California - San Diego
      • Los Angeles, California, Spojené státy, 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.
      • Sacramento, California, Spojené státy, 95817
        • University of California, Davis - Health Systems
      • Santa Monica, California, Spojené státy, 90404
        • UCLA
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • University of Colorado Health Sciences Center
    • District of Columbia
      • Washington, District of Columbia, Spojené státy, 20007
        • Georgetown University Medical Center IRB
    • Florida
      • Fort Myers, Florida, Spojené státy, 33916-2233
        • Florida Cancer Specialists
      • Saint Petersburg, Florida, Spojené státy, 33705
        • Florida Cancer Specialists
      • Tampa, Florida, Spojené státy, 33612
        • H Lee Moffitt Cancer Center
    • Georgia
      • Athens, Georgia, Spojené státy, 30607
        • Northeast Georgia Cancer Care, LLC
      • Atlanta, Georgia, Spojené státy, 30322
        • Emory University
    • Iowa
      • Iowa City, Iowa, Spojené státy, 52242
        • University of Iowa Hospital
    • Kansas
      • Westwood, Kansas, Spojené státy, 66205
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Spojené státy, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Spojené státy, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, Spojené státy, 63110
        • Washington University Medical Center
    • Montana
      • Billings, Montana, Spojené státy, 59101
        • Billings Clinic Research Center
    • New Hampshire
      • Lebanon, New Hampshire, Spojené státy, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, Spojené státy, 10032
        • Columbia University
    • North Carolina
      • Charlotte, North Carolina, Spojené státy, 28204
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45242
        • Oncology Hematology Care Inc
    • Oregon
      • Portland, Oregon, Spojené státy, 97213
        • Portland VA Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Spojené státy, 37404
        • Tennessee Oncology PLLC
      • Memphis, Tennessee, Spojené státy, 38120
        • The West Clinic
      • Nashville, Tennessee, Spojené státy, 37203
        • Tennessee Oncology PLLC
    • Washington
      • Kirkland, Washington, Spojené státy, 98034
        • MS Center at Evergreen
      • Seattle, Washington, Spojené státy, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Spojené státy, 98112
        • Group Health
      • Tacoma, Washington, Spojené státy, 98405
        • MultiCare Health System
  • Španělsko
      • Badalona, Španělsko, 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.
      • Pamplona, Španělsko, 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.
      • Valencia, Španělsko, 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.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Emibetuzumab
Administered IV
Ostatní jména:
  • LY2875358
Lék: Erlotinib
Podává se ústně
Experimentální: 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.
Lék: Emibetuzumab
Administered IV
Ostatní jména:
  • LY2875358

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Časové okno: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
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.
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression Free Survival (PFS)
Časové okno: Baseline to Objective Disease Progression or Death (Up to 24 Months)

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)
Time to Progressive Disease
Časové okno: Baseline to Objective Disease Progression (Up to 24 Months)
Baseline to Objective Disease Progression (Up to 24 Months)
Change in Tumor Size (CTS)
Časové okno: Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.
Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
Časové okno: Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
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.
Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Duration of Response (DoR)
Časové okno: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
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.
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Overall Survival (OS)
Časové okno: Baseline to Death Due to Any Cause (Up to 24 Months)
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.
Baseline to Death Due to Any Cause (Up to 24 Months)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Časové okno: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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.
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Časové okno: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
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.
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
Časové okno: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)

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)
Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
Časové okno: 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
AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.
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
Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
Časové okno: Baseline through 30-Day Follow-Up (Up to 24 Months)
Baseline through 30-Day Follow-Up (Up to 24 Months)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eli Lilly and Company

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2013

Primární dokončení (Aktuální)

1. února 2015

Dokončení studie (Aktuální)

1. března 2016

Termíny zápisu do studia

První předloženo

12. července 2013

První předloženo, které splnilo kritéria kontroly kvality

12. července 2013

První zveřejněno (Odhad)

16. července 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. září 2019

Naposledy ověřeno

1. září 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 14208
  • I4C-MC-JTBC (Jiný identifikátor: Eli Lilly and Company)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Popis plánu 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.

Časový rámec sdílení 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.

Kritéria přístupu pro sdílení IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Typ podpůrných informací pro sdílení IPD

  • Protokol studie
  • Plán statistické analýzy (SAP)
  • Zpráva o klinické studii (CSR)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Karcinom, nemalobuněčné plíce

Klinické studie na Emibetuzumab

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Zdravotní podmínky

Drogové intervence

CROs by country

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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