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 de Elche; 🇪🇸 Elche, Alicante, Spain

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

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

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

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