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

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT03132493
• Lead Sponsor: Spanish Lung Cancer Group

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.

Study Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-27
• Study Start: 2017-06-01
• Primary Completion: 2017-12-01
• Study Completion: 2018-09-15
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free survival	At 12 months	time from inclusion to progression

Secondary Outcome Measures

Name	Time	Method
Overall Response rate	At 12 months	Percentage of patient reaching a complete, partial or stable disease

Trial Locations

Locations (61)

Hospital Virgen de los Lirios; 🇪🇸 Alcoy, Alicante, Spain

Hospital Universitario de Vinalopó; 🇪🇸 Elche, Alicante, Spain

H. Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital General Universitario de Elda; 🇪🇸 Elda, Alicante, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Corporació Sanitaria Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitari Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitario de Donostia; 🇪🇸 Donostia, Gipuzkoa, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Centro Oncológico de Galicia; 🇪🇸 A Coruña, La Coruña, Spain

Hospital Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain

Hospital Universitario de Móstoles; 🇪🇸 Móstoles, Madrid, Spain

Hospital Universitario Infanta Cristina; 🇪🇸 Parla, Madrid, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital de Cruces; 🇪🇸 Baracaldo, Vizcaya, Spain

Hospital Lluís Alcanyís; 🇪🇸 Xàtiva, Valencia, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Vizcaya, Spain

Hospital Vall d' Hebron; 🇪🇸 Barcelona, Spain

Hospital de Sant Pau Y de La Santa Creu; 🇪🇸 Barcelona, Spain

H. Universitario Quirón Dexeus; 🇪🇸 Barcelona, Spain

H. Althaia; 🇪🇸 Barcelona, Spain

Hospital Virgen de la Luz; 🇪🇸 Cuenca, Spain

Hospital de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Clínico San Cecilio; 🇪🇸 Granada, Spain

Hospital Dr. Josep Trueta; 🇪🇸 Girona, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Hospital Universitario a Coruña; 🇪🇸 La Coruña, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

H.U. Puerta de Hierro; 🇪🇸 Madrid, Spain

MD Anderson Cancer Center; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Fundación Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Infanta Sofía; 🇪🇸 Madrid, Spain

H. Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Spain

H. Son Llàtzer; 🇪🇸 Palma de Mallorca, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital General de Valencia; 🇪🇸 Valencia, Spain

H. Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Clinico de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Nuestra Señora Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Dr. Peset; 🇪🇸 Valencia, Spain

Hospital de Sagunto; 🇪🇸 Valencia, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

H. Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario de Áraba; 🇪🇸 Vitoria, Áraba, Spain

Hospital Universitario Quirón Madrid; 🇪🇸 Pozuelo De Alarcón, Madrid, Spain

Hospital de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital de Galdakao; 🇪🇸 Galdakao, Bizkaia, Spain

Hospital Insular de Gran Canaria; 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain