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Clinical Trials/NCT01333007
NCT01333007CompletedNot Applicable

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.

Hoffmann-La Roche0 sites423 target enrollmentStarted: July 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
423
Primary Endpoint
Progression-free survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: 18 months

Secondary Outcomes

  • Overall survival(18 months)
  • Quality of Life: Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire(18 months)
  • Clinical (diagnosis, therapies, comorbidity) and demographic characteristics of patients initiated on Avastin treatment(18 months)
  • Treatment of non-squamous NSCLC in clinical practice(18 months)
  • Modality of treatment with Avastin (dose, duration, associated chemotherapy)(18 months)
  • Safety: Incidence of adverse events(18 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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