An Observational Study on Patients With Non-Squamous NSCLC Who Reached A Long PFS After Avastin (Bevacizumab)-Based First-Line Therapy

November 1, 2016 updated by: Hoffmann-La Roche

Retrospective Study to Determinate the Clinical Phenotype of Patients With Non Squamous NSCLC Treated With First Line Bevacizumab-based Therapy That Reached a Long PFS

This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 3010
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08916
      • Barcelona, Spain, 08028
      • Caceres, Spain, 10003
      • Jaen, Spain, 23007
      • Leon, Spain, 24071
      • Lugo, Spain, 27004
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28007
      • Madrid, Spain, 28033
      • Madrid, Spain, 28050
      • Madrid, Spain, 28935
      • Malaga, Spain, 29010
      • Murcia, Spain, 30008
      • Navarra, Spain, 31008
      • Pontevedra, Spain, 36002
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46017
      • Valencia, Spain, 46026
      • Valencia, Spain, 46015
      • Zaragoza, Spain, 50009
    • Alicante
      • Alcoy, Alicante, Spain, 03804
      • Elche, Alicante, Spain, 03203
      • Elda, Alicante, Spain, 03600
    • Almeria
      • Almería, Almeria, Spain, 04009
    • Guipuzcoa
      • San Sebastian de Los Reyes, Guipuzcoa, Spain, 28702
    • Islas Baleares
      • Manacor, Islas Baleares, Spain, 07500
      • Palma de Mallorca, Islas Baleares, Spain, 07012
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Non squamous NSCLC patients treated with bevacizumab-based first line therapy and PFS >/= 9 months

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy
  • Progression-free survival of >/= 9 months reached

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (>9 months) according to clinical phenotype
Time Frame: approximately 9 months
approximately 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: approximately 9 months
approximately 9 months
Safety: Incidence of adverse events
Time Frame: approximately 9 months
approximately 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25494

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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