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E1505 -- Adjuvant Chemotherapy With or Without Bevacizumab for Completely Resected Stage IB (> 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (> 4 cm) - IIIA non-small cell lung cancer.

We propose that adding bevacizumab to a cisplatin treatment (either with Pemetrexed, Vinorelbine, Docetaxel, or Gemcitabine) will increase survival advantages for patients. Bevacizumab is the first agent ever shown to prolong survival when added to frontline chemotherapy for advanced NSCLC.


Eligibility

You may be eligible for this trial if:

  • You have undergone complete resection of your non-small cell lung cancer [stage IB (> 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2)]. Accepted types of resection are lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy. Resections by segmentectomy or wedge resection will not be accepted. Mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors).
  • You must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered from surgery.
  • You are at least 18 years old
  • You must not have received:
    • Prior systemic chemotherapy at any time.
    • Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable.)

Trial Sponsor

  • Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

  • Dec 2007

Tentative Project End Date

  • Jun 2011

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .