Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient (NIVEX)

Spanish Lung Cancer Group

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Nivolumab 10 MG/ML

Study type: Observational

Funder types: Other

Identifiers

NCT03132493

GECP 16/05_NIVEX

Details and patient eligibility

About

The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.

A standard anonymous data collection form will be used to collect data and to analyze it.

Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.

Full description

This study will help to understand the efficacy of Nivolumab in the real world setting within the SPANISH expanded access programme.

The main objective of this study is to evaluate nivolumab efficacy in terms of Overall Survival (OS), Progression Free Survival (PFS), Overall Response Rate (ORR) and safety in the clinical practice.

The efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.

Enrollment: 676 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)
2. Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care

Exclusion criteria

1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
2. Patients who were accepted in the EAP but do not receive treatment