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

Sponsor

Spanish Lung Cancer Group (Other)

Overall Status

Completed

CT.gov ID

NCT03132493

Collaborator

(none)

676

Enrollment

Locations

15.5

Actual Duration (Months)

11.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Nivolumab 10 MG/ML

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 Design

Study Type:

Observational

Actual Enrollment :

676 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Sep 15, 2018

Outcome Measures

Primary Outcome Measures

Progression Free survival [At 12 months]
time from inclusion to progression

Secondary Outcome Measures

Overall Response rate [At 12 months]
Percentage of patient reaching a complete, partial or stable disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)
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:

Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
Patients who were accepted in the EAP but do not receive treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Virgen de los Lirios	Alcoy	Alicante	Spain	03804
2	Hospital de Elche	Elche	Alicante	Spain	03202
3	Hospital Universitario de Vinalopó	Elche	Alicante	Spain	03293
4	Hospital General Universitario de Elda	Elda	Alicante	Spain	03600
5	H. Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
6	Hospital de Mataró	Mataró	Barcelona	Spain	08304
7	Corporació Sanitaria Parc Taulí	Sabadell	Barcelona	Spain	08208
8	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain	08220
9	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona	Spain	08221
10	Hospital de Galdakao	Galdakao	Bizkaia	Spain	48960
11	Hospital Universitario de Donostia	Donostia	Gipuzkoa	Spain	20014
12	Centro Oncológico de Galicia	A Coruña	La Coruña	Spain	15009
13	Hospital Insular de Gran Canaria	Las Palmas de Gran Canaria	Las Palmas	Spain
14	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid	Spain	28922
15	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid	Spain	28942
16	Hospital Severo Ochoa	Leganés	Madrid	Spain	28911
17	Hospital Universitario de Móstoles	Móstoles	Madrid	Spain	28935
18	Hospital Universitario Infanta Cristina	Parla	Madrid	Spain	28981
19	Hospital Universitario Quirón Madrid	Pozuelo De Alarcón	Madrid	Spain	Madrid
20	Clínica Universitaria de Navarra	Pamplona	Navarra	Spain	31008
21	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008
22	Hospital Sant Joan de Reus	Reus	Tarragona	Spain	43204
23	Hospital Lluís Alcanyís	Xàtiva	Valencia	Spain	46800
24	Hospital de Cruces	Baracaldo	Vizcaya	Spain	48903
25	Hospital de Basurto	Bilbao	Vizcaya	Spain	48013
26	Hospital del Mar	Barcelona		Spain	08003
27	Hospital Vall d' Hebron	Barcelona		Spain	08035
28	H. Universitario Quirón Dexeus	Barcelona		Spain	08036
29	Hospital de Sant Pau Y de La Santa Creu	Barcelona		Spain	08036
30	H. Althaia	Barcelona		Spain	08243
31	Hospital Virgen de la Luz	Cuenca		Spain	16002
32	Hospital Dr. Josep Trueta	Girona		Spain	17007
33	Hospital Clínico San Cecilio	Granada		Spain	18012
34	Hospital de Guadalajara	Guadalajara		Spain	19002
35	Complejo Hospitalario de Jaén	Jaén		Spain	23007
36	Hospital Universitario a Coruña	La Coruña		Spain	15006
37	Complejo Asistencial Universitario de León	León		Spain	24071
38	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
39	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
40	MD Anderson Cancer Center	Madrid		Spain	28033
41	H.U. Puerta de Hierro	Madrid		Spain	28035
42	Fundación Jimenez Diaz	Madrid		Spain	28040
43	Hospital Clínico San Carlos	Madrid		Spain	28040
44	Hospital Universitario Infanta Sofía	Madrid		Spain	28703
45	H. Morales Messeguer	Murcia		Spain	30008
46	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia		Spain	30120
47	H. Carlos Haya	Málaga		Spain	29010
48	Hospital Universitario Virgen de la Victoria	Málaga		Spain	29010
49	Hospital Son Espases	Palma de Mallorca		Spain	07010
50	H. Son Llàtzer	Palma de Mallorca		Spain	07198
51	Hospital Clinico de Salamanca	Salamanca		Spain	37007
52	Hospital Nuestra Señora Candelaria	Santa Cruz de Tenerife		Spain	38010
53	Hospital Virgen del Rocío	Sevilla		Spain	41013
54	Instituto Valenciano de Oncología	Valencia		Spain	46009
55	Hospital General de Valencia	Valencia		Spain	46014
56	Hospital Dr. Peset	Valencia		Spain	46017
57	Hospital de Sagunto	Valencia		Spain	46500
58	Hospital La Fe	Valencia		Spain
59	Hospital Clínico Universitario de Valladolid	Valladolid		Spain	47003
60	H. Miguel Servet	Zaragoza		Spain	50009
61	Hospital Universitario de Áraba	Vitoria	Áraba	Spain	01009

Sponsors and Collaborators

Spanish Lung Cancer Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Spanish Lung Cancer Group

ClinicalTrials.gov Identifier:

NCT03132493

Other Study ID Numbers:

GECP 16/05_NIVEX

First Posted:

Apr 27, 2017

Last Update Posted:

Nov 14, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Nivolumab

Study Results

No Results Posted as of Nov 14, 2018