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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 June 2023 |
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Main ID: |
NCT02933346 |
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Date of registration:
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12/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program
CLINIVO |
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Scientific title:
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Assessment and Follow-up of Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Nivolumab Under the French Temporary Authorization for Use (ATU) Program |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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907 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02933346 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Olivier MOLINIER, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CH Le Mans, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients with advanced NSCLC, non-eligible for thoracic radiation therapy, having
received nivolumab (at least one injection), under nominative or cohort ATU, between
23-JAN-2015 and 31-AUG-2015 (end of ATU).
Exclusion Criteria:
- patients included in a biomedical research trial with nivolumab
- patients <18 years old
- patients included under ATU to receive nivolumab administration, but never did
- patients with a psychiatric history that hinders the comprehension of the information
leaflet
- patients refusing their data being collected
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Long-term Adverse Effects
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Non-small Cell Lung Cancer
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Nivolumab
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Primary Outcome(s)
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overall survival
[Time Frame: January 2015 - December 2017]
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Secondary Outcome(s)
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efficacy of the first systemic treatment post-nivolumab
[Time Frame: January 2015 - December 2017]
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efficacy of nivolumab
[Time Frame: January 2015 - December 2017]
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maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
[Time Frame: January 2015 - December 2017]
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Secondary ID(s)
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IFCT-1502 CLINIVO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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