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A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC


Inclusion Criteria:



- adult patients, >=18 years of age;

- documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;

- adequate liver and kidney function;

- women of childbearing potential must have a negative serum pregnancy test within 7
days of starting study treatment.

Exclusion Criteria:

- prior chemotherapy or treatment with another systemic cancer therapy;

- surgery (including open biopsy), significant traumatic injury, or radiotherapy within
the last 4 weeks prior to first dose of study treatment;

- brain metastasis or spinal cord compression;

- fertile men, and women of childbearing potential, not using adequate contraception;

- treatment with any other investigational agent, or participation in another clinical
trial, within 30 days prior to entering the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

BO17704

NCT ID:

NCT00806923

Start Date:

February 2005

Completion Date:

February 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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