Clinical trial NCT00130728 (phase 3, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bevacizumab, erlotinib hcl, placebo
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  Cytologically or histologically confirmed NSCLC

          -  Clinical or radiographic progression during or after first-line chemotherapy or
             chemoradiotherapy for NSCLC

          -  Consent to provide archival tissue for analysis is required for participation in this
             study

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Age ≥ 18 years

          -  Use of an acceptable means of contraception for men and women of childbearing
             potential

          -  International normalized ratio (INR) no greater than 1.3 and an aPTT no greater than
             the upper limits of normal within 28 days prior to enrollment for patients not on
             low-molecular-weight heparin or fondaparinux

        Exclusion Criteria:

          -  Squamous cell carcinoma

          -  Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth
             Factor Receptor (EGFR) pathway or anti-angiogenesis agent

          -  Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior
             to randomization

          -  Local palliative radiotherapy within 14 days prior to randomization or persistent
             adverse effects from radiotherapy that have not resolved to Grade 2 or less following
             completion of treatment

          -  Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4
             weeks of Day 0

          -  Neurosurgery for brain metastases within 24 weeks of Day 0

          -  Brain biopsy within 12 weeks of Day 0

          -  Current use of dexamethasone for treatment associated with brain metastases

          -  History of gross hemoptysis within 3 months prior to randomization unless definitively
             treated with surgery or radiation

          -  History of any of the following within 6 months prior to Day 0: serious systemic
             disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA)
             Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia
             requiring medication, clinically significant peripheral vascular disease, abdominal
             fistula, gastrointestinal perforation, or intra-abdominal abscess

          -  Evidence of bleeding diathesis or coagulopathy or other serious or acute internal
             bleeding within 6 months prior to randomization

          -  Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke
             (hemorrhagic or thrombotic) within the last 6 months

          -  Progressive neurologic symptoms in patients with a history of brain metastases

          -  Full-dose anticoagulation with warfarin

          -  Chronic daily use of aspirin or other full-dose nonsteroidal anti-inflammatory drugs
             (NSAIDs) with anti-platelet activity

          -  In-patient surgical procedure, open biopsy, or significant traumatic injury within 28
             days prior to randomization

          -  Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior
             to randomization

          -  Anticipation of need for a major surgical procedure during the course of the study

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

          -  Inability to take oral medication or requirement for intravenous (IV) alimentation or
             total parenteral nutrition with lipids, or prior surgical procedures affecting
             absorption

          -  Pregnancy or breast-feeding

          -  Presence of another invasive cancer within 5 years prior to randomization

          -  Evidence of confusion or disorientation, or history of major psychiatric illness that
             may impair the patient's understanding of the Informed Consent Form or their ability
             to comply with study requirements