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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Jaen
      • La Coruña, Spain, 15006
        • Hospital Universitario A Coruña
      • León, Spain, 24071
        • Complejo Asistencial Universitario de Leon
      • 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 Clínico 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 Llatzer
      • Salamanca, Spain, 37007
        • Hospital Clínico 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 Oncología
      • 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 Vinalopó
      • 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 Mataró
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • 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 Oncologico de Galicia
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain
        • Hospital Insular de Gran Canaria
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundación Alcorcón
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Leganés, Madrid, Spain, 28911
        • Hospital Severo Ochoa
      • Móstoles, Madrid, Spain, 28935
        • Hospital Universitario de Móstoles
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Lung Cancer Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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