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

Non Small Cell Lung Cancer Clinical Trial

— NIVEX

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT03132493
Other study ID #	GECP 16/05_NIVEX
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	June 1, 2017
Est. completion date	September 15, 2018

Study information
Verified date	November 2018
Source	Spanish Lung Cancer Group
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	676
Est. completion date	September 15, 2018
Est. primary completion date	December 1, 2017
Accepts healthy volunteers	No
Gender	All
Age group	N/A and older
Eligibility	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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nivolumab 10 MG/ML
nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression

Locations
Country	Name	City	State
Spain	Centro Oncológico de Galicia	A Coruña	La Coruña
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	H. Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Cruces	Baracaldo	Vizcaya
Spain	H. Althaia	Barcelona
Spain	H. Universitario Quirón Dexeus	Barcelona
Spain	Hospital de Sant Pau Y de La Santa Creu	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d' Hebron	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital Virgen de la Luz	Cuenca
Spain	Hospital Universitario de Donostia	Donostia	Gipuzkoa
Spain	Hospital de Elche	Elche	Alicante
Spain	Hospital Universitario de Vinalopó	Elche	Alicante
Spain	Hospital General Universitario de Elda	Elda	Alicante
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital de Galdakao	Galdakao	Bizkaia
Spain	Hospital Dr. Josep Trueta	Girona
Spain	Hospital Clínico San Cecilio	Granada
Spain	Hospital de Guadalajara	Guadalajara
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario a Coruña	La Coruña
Spain	Hospital Insular de Gran Canaria	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Fundación Jimenez Diaz	Madrid
Spain	H.U. Puerta de Hierro	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Infanta Sofía	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	H. Carlos Haya	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid
Spain	H. Morales Messeguer	Murcia
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	H. Son Llàtzer	Palma de Mallorca
Spain	Hospital Son Espases	Palma de Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Infanta Cristina	Parla	Madrid
Spain	Hospital Universitario Quirón Madrid	Pozuelo De Alarcón	Madrid
Spain	Hospital Sant Joan de Reus	Reus	Tarragona
Spain	Corporació Sanitaria Parc Taulí	Sabadell	Barcelona
Spain	Hospital Clinico de Salamanca	Salamanca
Spain	Hospital Nuestra Señora Candelaria	Santa Cruz de Tenerife
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona
Spain	Hospital de Sagunto	Valencia
Spain	Hospital Dr. Peset	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario de Áraba	Vitoria	Áraba
Spain	Hospital Lluís Alcanyís	Xàtiva	Valencia
Spain	H. Miguel Servet	Zaragoza

Sponsors *(1)*
Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free survival	time from inclusion to progression	At 12 months
Secondary	Overall Response rate	Percentage of patient reaching a complete, partial or stable disease	At 12 months

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External Links

Link

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

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome

External Links