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

Study Overview
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Brief Summary
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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
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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.

Official 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

Conditions
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Non-small Cell Lung Cancer, Nivolumab, Long-term Adverse Effects

Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time from start of treatment to death from any cause | January 2015 - December 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of nivolumab | progression-free survival, best overall response, exposure time | 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) | January 2015 - December 2017 | 
| efficacy of the first systemic treatment post-nivolumab | progression-free survival, best response | January 2015 - December 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nivolumab, Real-world study, IFCT