A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab; placebo; erlotinib HCl
Intervention description: Intravenous repeating dose; Oral repeating dose; Oral repeating dose
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Lung Cancer; ATLAS; Avastin; Tarceva

Summary:

      This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the
      safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus
      bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.
    

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)