An observational study in Non-small Cell Lung Cancer, Nivolumab and Long-term Adverse Effects, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 72 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 907 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
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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:
overall survival
time from start of treatment to death from any cause
Time frame: January 2015 - December 2017
efficacy of nivolumab
progression-free survival, best overall response, exposure time
Time frame: January 2015 - December 2017
maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
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)
Time frame: January 2015 - December 2017
efficacy of the first systemic treatment post-nivolumab
progression-free survival, best response
Time frame: January 2015 - December 2017
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Intergroupe Francophone de Cancerologie Thoracique