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

NCT ID: NCT03132493

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

676 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Nivolumab 10 MG/ML

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

Intervention Type DRUG

Other Intervention Names

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Opdivo

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Lung Cancer Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delvys Rodríguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Insular de Gran Canaria

Margarita Majem, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

Site Status

Hospital de Elche

Elche, Alicante, Spain

Site Status

Hospital Universitario de Vinalopó

Elche, Alicante, Spain

Site Status

Hospital General Universitario de Elda

Elda, Alicante, Spain

Site Status

H. Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital de Mataró

Mataró, Barcelona, Spain

Site Status

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital de Galdakao

Galdakao, Bizkaia, Spain

Site Status

Hospital Universitario de Donostia

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Centro Oncológico de Galicia

A Coruña, La Coruña, Spain

Site Status

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Site Status

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Site Status

Hospital Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Site Status

Hospital Universitario Infanta Cristina

Parla, Madrid, Spain

Site Status

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Sant Joan de Reus

Reus, Tarragona, Spain

Site Status

Hospital Lluís Alcanyís

Xàtiva, Valencia, Spain

Site Status

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Site Status

Hospital de Basurto

Bilbao, Vizcaya, Spain

Site Status

Hospital Universitario a Coruña

A Coruña, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Vall d' Hebron

Barcelona, , Spain

Site Status

H. Universitario Quirón Dexeus

Barcelona, , Spain

Site Status

Hospital de Sant Pau Y de La Santa Creu

Barcelona, , Spain

Site Status

H. Althaia

Barcelona, , Spain

Site Status

Hospital Virgen de la Luz

Cuenca, , Spain

Site Status

Hospital Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital Clínico San Cecilio

Granada, , Spain

Site Status

Hospital de Guadalajara

Guadalajara, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Complejo Asistencial Universitario de León

León, , Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

MD Anderson Cancer Center

Madrid, , Spain

Site Status

H.U. Puerta de Hierro

Madrid, , Spain

Site Status

Fundación Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Infanta Sofía

Madrid, , Spain

Site Status

H. Carlos Haya

Málaga, , Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

H. Morales Messeguer

Murcia, , Spain

Site Status

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status

Hospital Son Espases

Palma de Mallorca, , Spain

Site Status

H. Son Llàtzer

Palma de Mallorca, , Spain

Site Status

Hospital Clinico de Salamanca

Salamanca, , Spain

Site Status

Hospital Nuestra Señora Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Virgen del Rocío

Seville, , Spain

Site Status

Instituto Valenciano de Oncología

Valencia, , Spain

Site Status

Hospital General de Valencia

Valencia, , Spain

Site Status

Hospital Dr. Peset

Valencia, , Spain

Site Status

Hospital de Sagunto

Valencia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

H. Miguel Servet

Zaragoza, , Spain

Site Status

Hospital Universitario de Áraba

Vitoria-Gasteiz, Áraba, Spain

Site Status

Countries

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Spain

Related Links

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http://www.gecp.org

Related Info

Other Identifiers

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GECP 16/05_NIVEX

Identifier Type: -

Identifier Source: org_study_id

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