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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Spanish Lung Cancer Group
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT03132493
First received: April 25, 2017
Last updated: April 26, 2017
Last verified: April 2017
  Purpose

We will 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 Intervention
Nivolumab Treatment in Expanded Use in Real World
Drug: Nivolumab 10 MG/ML

Study Type: Observational
Study Design: Observational Model: Other
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

Resource links provided by NLM:


Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:
  • Progression Free survival [ Time Frame: At 12 months ]
    time from inclusion to progression


Secondary Outcome Measures:
  • Overall Response rate [ Time Frame: At 12 months ]
    Percentage of patient reaching a complete, partial or stable disease


Estimated Enrollment: 1000
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nivolumab 10 MG/ML
    nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression
    Other Name: Opdivo
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03132493

Locations
Spain
H. Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Enric Carcereny, MD    + 34 93 430 20 06    ecarcereny@iconcologia.net   
Principal Investigator: Enric Carcereny, MD         
Consorci Sanitari de Terrassa Not yet recruiting
Terrassa, Barcelona, Spain, 08220
Contact: Remei Blanco, MD-PhD    +34 93 430 20 06    rblanco@cst.cat   
Contact       epereira@gecp.org   
Principal Investigator: Remei Blanco, MD-PhD         
Hospital Insular de Gran Canaria Not yet recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Contact: Delvys Rodríguez, MD    +34 93 430 20 06    delvysra@yahoo.com   
Principal Investigator: Delvys Rodríguez, MD         
Hospital de Sant Pau Y de La Santa Creu Not yet recruiting
Barcelona, Spain, 08036
Contact: Margarita Majem, MD    +34 93 430 20 06    MMajem@santpau.cat   
Principal Investigator: Margarita Majem, MD         
Sponsors and Collaborators
Spanish Lung Cancer Group
  More Information

Additional Information:
Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT03132493     History of Changes
Other Study ID Numbers: GECP 16/05_NIVEX
Study First Received: April 25, 2017
Last Updated: April 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2017