Trial Information

Summary: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4.0 cm) - IIIA Non Small Cell Lung Cancer (NSCLC)

Lung cancer remains the leading cause of cancer deaths in the United States and world-wide. This study is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have their lung cancer come back.

The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance of no recurrence for patients who have had surgery for the removal of the lung cancer.

You may be eligible to participate in this trial if:

• Age 18 or older.
• Complete resection of the lung cancer.
• If tumor is stage is IB, tumor must be greater than or equal to 4.0 cm.
• Patients must have had surgery no less than 6 weeks and no more than 12 weeks prior to entry into the study.
• Patients may not have received the following prior to entry into the study:
• Prior chemotherapy at any time.
• Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of study entry.
• No history of cancer within five years of study entry.
• Acceptable laboratory blood and urine tests per study criteria within two weeks of study entry.

You may be ineligible to participate in this trial if:

• History of heartattack or angina within 12 months of study entry.
• History of stroke (CVA and/or TIA)
• Women cannot be pregnant or breast feeding.
• Uncontrolled hypertension.
• Blood coagulation disorders
• Active infection, symptomatic congestive heart failure, cardiac arrhythmia, psychiatric illness/social situations or any other medical conditions that would compliance with the study requirements.
• Non-healing wound or bone fracture.
• Abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days of study entry.
• Known sensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
• Other study specific exclusion may apply.

Primary Outcomes: To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (equal to or greater than 4.0 cm) - IIIA Non-Small Cell Lung Cancer -NSCLC

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Trial listings updated: April 24, 2008 at 2:50:54 PM