A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) - IIIA Non- Small Cell Lung Cancer (NSCLC)

INTERVENTION: Trade Name: Avastin Product Name: Bevacizumab Product Code: RO4876646 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974‐75‐3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 15‐ CONDITION: Completely Resected Stage IB (=4 cm)‐IIIA Non‐Small Cell Lung Cancer (NSCLC). ; MedDRA version: 17.1 Level: PT Classification code 10061873 Term: Non‐small cell lung cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Primary Objective; To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (> 4 cm) ‐ IIIA NSCLC.; Primary end point(s): Overall Survival Secondary Objective: Secondary Objectives; To evaluate disease free survival and toxicity with chemotherapy with or without; bevacizumab used in the adjuvant setting in patients with resected stage IB; (>/= 4 cm) ‐ IIIA NSCLC.; To perform analyses of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for; resected early stage NSCLC.; To determine whether smoking status is linked to outcome for patients with resected; stage IB (>/= 4 cm) ‐ IIIA NSCLC treated with chemotherapy with or without; bevacizumab in the adjuvant setting. Timepoint(s) of evaluation of this end point: Survival ‐ patients will be followed up for 10 years. SECONDARY OUTCOME: Secondary end point(s): ‐ Disease free survival ; ‐ analysis of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab ; ‐ Determine whether smoking status is linked to outcome Timepoint(s) of evaluation of this end point: ‐ Disease free survival ‐ patients will be followed up for 10 years ; ‐ analysis of tissue and blood ‐ samples will be collected at the following time points: pre‐study, Week 13, Week 25 and Month 15 (Arm B only) ; ‐ Determine whether smoking status is linked to outcome ‐ smoking surveys will be completed 3 monthly post registration up to 12 months INCLUSION CRITERIA: 1.0 In order to be eligible for this trial, patients must have undergone complete resection of their non‐small cell lung cancer (NSCLC) [stage IB (=/= 4 cm) ‐ IIIA (T2‐3N0, T1‐3N1, T1‐3N2) prior to enrollment. (Refer to Appendix X for staging guidelines per AJCC 6th edition). Accepted types of resection will consist of 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‐operative (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors). Please refer to Section 5 for specific details on lymph node level sampling requirements and resection criteria. 2.0 Patients must be no less than 6 weeks (42 days) and no more (84 days) than 12 weeks post‐thoracotomy at the time of randomization and must be adequately recovered from surgery. 3.0 Age = 18 years