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

November 12, 2018 updated by: Spanish Lung Cancer Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

676

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d' Hebron
      • Barcelona, Spain, 08036
        • H. Universitario Quirón Dexeus
      • Barcelona, Spain, 08036
        • Hospital de Sant Pau Y de La Santa Creu
      • Barcelona, Spain, 08243
        • H. Althaia
      • Cuenca, Spain, 16002
        • Hospital Virgen De La Luz
      • Girona, Spain, 17007
        • Hospital Dr. Josep Trueta
      • Granada, Spain, 18012
        • Hospital Clínico San Cecilio
      • Guadalajara, Spain, 19002
        • Hospital de Guadalajara
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén
      • La Coruña, Spain, 15006
        • Hospital Universitario A Coruña
      • León, Spain, 24071
        • Complejo Asistencial Universitario de León
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28035
        • H.U. Puerta de Hierro
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center
      • Madrid, Spain, 28703
        • Hospital Universitario Infanta Sofía
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca
      • Murcia, Spain, 30008
        • H. Morales Messeguer
      • Málaga, Spain, 29010
        • H. Carlos Haya
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain, 07010
        • Hospital Son Espases
      • Palma de Mallorca, Spain, 07198
        • H. Son Llàtzer
      • Salamanca, Spain, 37007
        • Hospital Clinico De Salamanca
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Nuestra Señora Candelaria
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocio
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Valencia, Spain, 46014
        • Hospital General de Valencia
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain, 46017
        • Hospital Dr. Peset
      • Valencia, Spain, 46500
        • Hospital de Sagunto
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • H. Miguel Servet
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Hospital Virgen de los Lirios
      • Elche, Alicante, Spain, 03202
        • Hospital de Elche
      • Elche, Alicante, Spain, 03293
        • Hospital Universitario de Vinalopo
      • Elda, Alicante, Spain, 03600
        • Hospital General Universitario de Elda
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • H. Germans Trias i Pujol
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataro
      • Sabadell, Barcelona, Spain, 08208
        • Corporació Sanitària Parc Taulí
      • Terrassa, Barcelona, Spain, 08220
        • Consorci Sanitari de Terrassa
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mutua de Terrassa
    • Bizkaia
      • Galdakao, Bizkaia, Spain, 48960
        • Hospital de Galdakao
    • Gipuzkoa
      • Donostia, Gipuzkoa, Spain, 20014
        • Hospital Universitario de Donostia
    • La Coruña
      • A Coruña, La Coruña, Spain, 15009
        • Centro Oncológico de Galicia
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain
        • Hospital Insular de Gran Canaria
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Leganés, Madrid, Spain, 28911
        • Hospital Severo Ochoa
      • Móstoles, Madrid, Spain, 28935
        • Hospital Universitario de Mostoles
      • Parla, Madrid, Spain, 28981
        • Hospital Universitario Infanta Cristina
      • Pozuelo De Alarcón, Madrid, Spain, Madrid
        • Hospital Universitario Quiron Madrid
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Sant Joan de Reus
    • Valencia
      • Xàtiva, Valencia, Spain, 46800
        • Hospital Lluis Alcanyis
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
    • Áraba
      • Vitoria, Áraba, Spain, 01009
        • Hospital Universitario de Araba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for the trial are those treated in the EAP of nivolumab in Spain. The total number of patients to be included will be 1400 from 150 participating sites in Spain (anticipated data)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free survival
Time Frame: At 12 months
time from inclusion to progression
At 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Lung Cancer Group

Investigators

  • Principal Investigator: Delvys Rodríguez, MD, PhD, Hospital Universitario Insular de Gran Canaria
  • Principal Investigator: Margarita Majem, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

September 15, 2018

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 16/05_NIVEX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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