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

A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03132493

Acronym

NIVEX

Enrollment

676

Registered

2017-04-27

Start date

2017-06-01

Completion date

2018-09-15

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief summary

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.

Detailed 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.

Interventions

DRUGNivolumab 10 MG/ML

nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Progression Free survival	At 12 months	time from inclusion to progression

Secondary

Measure	Time frame	Description
Overall Response rate	At 12 months	Percentage of patient reaching a complete, partial or stable disease

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026