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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01343914
First received: April 12, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (>9 months) according to clinical phenotype [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  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: NCT01343914

Locations
Spain
Alcoy, Alicante, Spain, 03804
Elche, Alicante, Spain, 03203
Elda, Alicante, Spain, 03600
Almería, Almeria, Spain, 04009
San Sebastian de Los Reyes, Guipuzcoa, Spain, 28702
Manacor, Islas Baleares, Spain, 07500
Palma de Mallorca, Islas Baleares, Spain, 07012
Santiago de Compostela, La Coruña, Spain, 15706
Vigo, Pontevedra, Spain, 36204
Alicante, Spain, 3010
Barcelona, Spain, 08916
Barcelona, Spain, 08028
Barcelona, Spain, 08041
Caceres, Spain, 10003
Jaen, Spain, 23007
Leon, Spain, 24071
Lugo, Spain, 27004
Madrid, Spain, 28034
Madrid, Spain, 28935
Madrid, Spain, 28033
Madrid, Spain, 28050
Madrid, Spain, 28040
Madrid, Spain, 28007
Madrid, Spain, 28046
Malaga, Spain, 29010
Murcia, Spain, 30008
Navarra, Spain, 31008
Pontevedra, Spain, 36002
Sevilla, Spain, 41013
Valencia, Spain, 46026
Valencia, Spain, 46017
Valencia, Spain, 46015
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01343914     History of Changes
Other Study ID Numbers: ML25494
Study First Received: April 12, 2011
Last Updated: August 19, 2014
Health Authority: Spain: Agencia Española de Medicamentos y productos sanitarios (AEMPyS)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014