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An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01333007
First received: April 6, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study of First-line Treatment of Patients With Unresectable Advanced (Stage IIIB), Metastatic (Stage IV) or Recurrent Non Squamous Non-small Cell Lung Cancer (NSCLC), Starting a Treatment With Bevacizumab (Avastin®) in Combination With Chemotherapy.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical (diagnosis, therapies, comorbidity) and demographic characteristics of patients initiated on Avastin treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Modality of treatment with Avastin (dose, duration, associated chemotherapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of Life: Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Treatment of non-squamous NSCLC in clinical practice [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 423
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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

Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
  • Treating physician's decision to initiate first-line Avastin treatment

Exclusion Criteria:

  • Participation in a clinical trial evaluating anti-cancer therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333007

  Show 151 Study Locations
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: NCT01333007     History of Changes
Other Study ID Numbers: ML22991
Study First Received: April 6, 2011
Last Updated: May 7, 2013
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

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 May 16, 2013