CTSU E5508: Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC

Purpose: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
Cancer () - Lung
Gary Goodman, M.D.
Swedish Cancer Institute

  • Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)
    • Predominant non-squamous histology
      • NSCLC not otherwise specified allowed
      • Mixed tumors are categorized by the predominant cell type
  • Must meet 1 of the following criteria:
    • Stage IV disease including M1a or M1b stages or recurrent disease
  • Stage IIIB (T4NX) disease with ipsilateral lung lobe allowed provided patients are not candidates for combined chemotherapy or radiotherapy
  • Patient must have an overall stable or better response after 4 courses of induction therapy
  • ECOG performance status 0-1
  • At least 12 months since prior adjuvant chemotherapy
  • At least 2 weeks since prior radiotherapy
  • Patients must not have had any major surgery such as thoracotomy, laparotomy, craniotomy, or significant traumatic injury within 6 weeks prior to registration
  • No prior systemic chemotherapy for advanced stage lung cancer
  • No prior paclitaxel, pemetrexed disodium, or bevacizumab
    • Prior carboplatin allowed provided it was given as part of adjuvant chemotherapy
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