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Open Label Study of Avastin in Combination With Platinum-containing Chemotherapy as 1st Line Treatment in Patients With Stage IIIb/IV Non-squamous NSCLC


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Open Label Study of Avastin in Combination With Platinum-containing Chemotherapy as 1st Line Treatment in Patients With Stage IIIb/IV Non-squamous NSCLC


Inclusion Criteria:



- adult patients, >=18 years of age;

- histologically or cytologically documented inoperable, locally advanced ( stage III),
metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed
histology should be categorized by the predominant cell type);

- ECOG PS status 0-2;

- life expectancy >= 12weeks;

- adequate renal, liver and hematological function.

Exclusion Criteria:

- mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a
predominant squamous component;

- hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;

- evidence of tumor invading major blood vessels on imaging;

- evidence of CNS metastases, even if previously treated.

- major surgery (including open biopsy), significant traumatic injury within 28 days
prior to enrolment, or anticipation of need for major surgery during study treatment;

- prior chemotherapy for stage IIIb/IV disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

AEs, laboratory parameters.

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Austria: Ministry of Health

Study ID:

MO19390

NCT ID:

NCT00451906

Start Date:

October 2006

Completion Date:

June 2009

Related Keywords:

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

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