Clinical trial NCT03132493: Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Spanish Lung Cancer Group
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 676
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free survival
timeFrame: At 12 months
Secondary outcomes:
measure: Overall Response rate
timeFrame: At 12 months
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Elche
country: Spain
facility: Hospital de Elche
state: Alicante
city: Elche
country: Spain
facility: Hospital Universitario de Vinalopó
state: Alicante
city: Elda
country: Spain
facility: Hospital General Universitario de Elda
state: Alicante
city: Badalona
country: Spain
facility: H. Germans Trias i Pujol
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Bizkaia
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Gipuzkoa
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
state: La Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria
state: Las Palmas
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Parla
country: Spain
facility: Hospital Universitario Infanta Cristina
state: Madrid
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quirón Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
state: Tarragona
city: Xàtiva
country: Spain
facility: Hospital Lluís Alcanyís
state: Valencia
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d' Hebron
city: Barcelona
country: Spain
facility: H. Universitario Quirón Dexeus
city: Barcelona
country: Spain
facility: Hospital de Sant Pau Y de La Santa Creu
city: Barcelona
country: Spain
facility: H. Althaia
city: Cuenca
country: Spain
facility: Hospital Virgen de la Luz
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: Granada
country: Spain
facility: Hospital Clínico San Cecilio
city: Guadalajara
country: Spain
facility: Hospital de Guadalajara
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: La Coruña
country: Spain
facility: Hospital Universitario a Coruña
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: H.U. Puerta de Hierro
city: Madrid
country: Spain
facility: Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Murcia
country: Spain
facility: H. Morales Messeguer
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. Carlos Haya
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Palma de Mallorca
country: Spain
facility: H. Son Llàtzer
city: Salamanca
country: Spain
facility: Hospital Clinico de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Señora Candelaria
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Valencia
country: Spain
facility: Hospital de Sagunto
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: H. Miguel Servet
city: Vitoria
country: Spain
facility: Hospital Universitario de Áraba
state: Áraba
Study officials:
affiliation: Hospital Universitario Insular de Gran Canaria
name: Delvys Rodríguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Margarita Majem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: