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A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy


Inclusion Criteria:



- adult patients, >=18 years of age;

- locally advanced metastatic or recurrent non-squamous non-small cell lung cancer
(NSCLC);

- >=1 measurable tumor lesion;

- ECOG performance status 0-1.

Exclusion Criteria:

- prior chemotherapy or treatment with another systemic anti-cancer agent;

- evidence of CNS metastases;

- history of grade 2 or higher hemoptysis;

- evidence of tumor invading or abutting major blood vessels;

- malignancies other than NSCLC within 5 years prior to randomization, other than
adequately treated cancer in situ of cervix, basal or squamous cell skin cancer,
localized prostate cancer or DCIS;

- clinically significant cardiovascular disease;

- current or recent use of aspirin (>325mg/day) or full dose anticoagulants or
thrombolytic agents for therapeutic purposes.

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:

Correlation of biomarkers with response rate, as assessed by the investigator.

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Denmark: Danish Medicines Agency

Study ID:

BO21015

NCT ID:

NCT00700180

Start Date:

September 2008

Completion Date:

July 2011

Related Keywords:

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

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