A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS) | NCT00257608 | Trialant

A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS) | NCT00257608 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Signed Informed Consent Form

Histologically or cytologically confirmed NSCLC

Advanced NSCLC or recurrent disease

INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.

18 years of age or older

For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study

Exclusion Criteria:

Prior systemic chemotherapy in the metastatic setting

Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms

Pregnancy or lactation

Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results

Active infection or a fever within 3 days of enrollment

Active malignancy other than lung cancer

Radiation therapy to sites other than whole brain within 14 days prior to enrollment

History of gross hemoptysis within 3 months prior to enrollment

Known hypersensitivity to any of the components of cytotoxic chemotherapy combinations, bevacizumab, or tyrosine kinase inhibitors

Inadequately controlled hypertension

Unstable angina or New York Heart Association Grade II or greater CHF

Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment

History of myocardial infarction within 6 months prior to enrollment

History of stroke within 6 months prior to enrollment

Symptomatic peripheral vascular disease within 6 months prior to enrollment

Evidence of bleeding diathesis or coagulopathy

Serious, non-healing wound, ulcer, or bone fracture

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment; anticipation of need for major surgical procedure during the course of the study

Current, recent, or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab/erlotinib study

Progressive neurologic symptoms in subjects with a history of brain metastases

History of significant vascular disease (e.g., aortic aneurysm)