Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program (CLINIVO)

Intergroupe Francophone de Cancerologie Thoracique

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02933346

IFCT-1502 CLINIVO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 907 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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