Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program
- Conditions
- Non-small Cell Lung CancerLong-term Adverse EffectsNivolumab
- Registration Number
- NCT02933346
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief 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.
- Detailed Description
Although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (NSCLC) types, most patients with advanced tumors are still treated with first-line chemotherapy. In 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. In France, besides the clinical trials, this molecule has been made available in January 2015 under a Temporary Authorization for Use (ATU, compassionate use).
Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the ATU 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 907
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival January 2015 - December 2017 time from start of treatment to death from any cause
- Secondary Outcome Measures
Name Time Method maximum toxicities of nivolumab treatment, including delayed toxicities (immune) January 2015 - December 2017 Maximum toxicity according to the investigator (Adverse events with NCI-CTC 4.0 Grade ≥2, categorized as: hepatic, pulmonary, endocrine, cutaneous, gastrointestinal, renal, hematologic, other immune toxicities)
efficacy of the first systemic treatment post-nivolumab January 2015 - December 2017 progression-free survival, best response
efficacy of nivolumab January 2015 - December 2017 progression-free survival, best overall response, exposure time
Trial Locations
- Locations (72)
CH du Pays d'Aix
🇫🇷Aix-En-Provence, France
Clinique du Rambot
🇫🇷Aix-En-Provence, France
CHU d'Amiens-Picardie
🇫🇷Amiens, France
CHU d'Angers
🇫🇷Angers, France
CH Argenteuil
🇫🇷Argenteuil, France
CH d'Avignon
🇫🇷Avignon, France
Institut Sainte Catherine
🇫🇷Avignon, France
CH de la Côte Basque
🇫🇷Bayonne, France
CHU de Besançon
🇫🇷Besançon, France
CH de Blois
🇫🇷Blois, France
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