CompletedNot Applicable

Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program

France907 participantsStarted 2016-09

Plain-language summary

Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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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

What they're measuring

overall survival

Timeframe: January 2015 - December 2017

Trial details

NCT IDNCT02933346

SponsorIntergroupe Francophone de Cancerologie Thoracique

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-01

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