A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)
6 septembre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
111
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Heidelberg, Allemagne, 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, Allemagne, 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.
-
-
-
-
-
Aalst, Belgique, 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, Belgique, 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, Belgique, 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, Belgique, 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.
-
-
-
-
-
Seoul, Corée, République de, 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.
-
-
-
-
-
Badalona, Espagne, 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, Espagne, 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, Espagne, 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.
-
-
-
-
-
Montpellier, France, 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, France, 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.
-
-
-
-
-
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.
-
Jerusalem, Israël, 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, 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.
-
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.
-
Tel Hashomer, Israël, 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, 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.
-
-
-
-
-
Milano, Italie, 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, Italie, 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.
-
-
-
-
-
Amsterdam, Pays-Bas, 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, Pays-Bas, 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.
-
-
-
-
Avon
-
Bristol, Avon, Royaume-Uni, 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, Royaume-Uni, 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, Royaume-Uni, 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, Royaume-Uni, 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, Royaume-Uni, 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.
-
-
-
-
Alabama
-
Birmingham, Alabama, États-Unis, 35294
- University of Alabama at Birmingham
-
-
California
-
La Jolla, California, États-Unis, 92037
- University of California - San Diego
-
Los Angeles, California, États-Unis, 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, États-Unis, 95817
- University of California, Davis - Health Systems
-
Santa Monica, California, États-Unis, 90404
- UCLA
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- University of Colorado Health Sciences Center
-
-
District of Columbia
-
Washington, District of Columbia, États-Unis, 20007
- Georgetown University Medical Center IRB
-
-
Florida
-
Fort Myers, Florida, États-Unis, 33916-2233
- Florida Cancer Specialists
-
Saint Petersburg, Florida, États-Unis, 33705
- Florida Cancer Specialists
-
Tampa, Florida, États-Unis, 33612
- H Lee Moffitt Cancer Center
-
-
Georgia
-
Athens, Georgia, États-Unis, 30607
- Northeast Georgia Cancer Care, LLC
-
Atlanta, Georgia, États-Unis, 30322
- Emory University
-
-
Iowa
-
Iowa City, Iowa, États-Unis, 52242
- University of Iowa Hospital
-
-
Kansas
-
Westwood, Kansas, États-Unis, 66205
- University of Kansas Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48201
- Karmanos Cancer Institute
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
-
-
Missouri
-
Saint Louis, Missouri, États-Unis, 63110
- Washington University Medical Center
-
-
Montana
-
Billings, Montana, États-Unis, 59101
- Billings Clinic Research Center
-
-
New Hampshire
-
Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center
-
-
New York
-
New York, New York, États-Unis, 10032
- Columbia University
-
-
North Carolina
-
Charlotte, North Carolina, États-Unis, 28204
- Carolinas Medical Center
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45242
- Oncology Hematology Care Inc
-
-
Oregon
-
Portland, Oregon, États-Unis, 97213
- Portland VA Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer Center
-
-
Tennessee
-
Chattanooga, Tennessee, États-Unis, 37404
- Tennessee Oncology PLLC
-
Memphis, Tennessee, États-Unis, 38120
- The West Clinic
-
Nashville, Tennessee, États-Unis, 37203
- Tennessee Oncology PLLC
-
-
Washington
-
Kirkland, Washington, États-Unis, 98034
- MS Center at Evergreen
-
Seattle, Washington, États-Unis, 98109
- Seattle Cancer Care Alliance
-
Seattle, Washington, États-Unis, 98112
- Group Health
-
Tacoma, Washington, États-Unis, 98405
- MultiCare Health System
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Administered IV
Autres noms:
Administré par voie orale
|
|
Expérimental: 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.
|
Administered IV
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression Free Survival (PFS)
Délai: 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
Délai: Baseline to Objective Disease Progression (Up to 24 Months)
|
Baseline to Objective Disease Progression (Up to 24 Months)
|
|
|
Change in Tumor Size (CTS)
Délai: 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)]
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: Baseline through 30-Day Follow-Up (Up to 24 Months)
|
Baseline through 30-Day Follow-Up (Up to 24 Months)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2013
Achèvement primaire (Réel)
1 février 2015
Achèvement de l'étude (Réel)
1 mars 2016
Dates d'inscription aux études
Première soumission
12 juillet 2013
Première soumission répondant aux critères de contrôle qualité
12 juillet 2013
Première publication (Estimation)
16 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 septembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 septembre 2019
Dernière vérification
1 septembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Inhibiteurs de protéine kinase
- Chlorhydrate d'erlotinib
Autres numéros d'identification d'étude
- 14208
- I4C-MC-JTBC (Autre identifiant: Eli Lilly and Company)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Rapport d'étude clinique (CSR)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .