A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab; Carboplatin; Paclitaxel
Intervention description: 15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3; Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles; Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BRIDGE; NSCLC; Lung Cancer; Avastin

Summary:

      This is an open-label, single-arm, multicenter pilot study to evaluate the safety and
      efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb
      with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell
      Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form(s)

          -  At least 18 years of age

          -  Advanced histologically or cytologically confirmed predominant squamous NSCLC

          -  Subjects with treated brain metastases are eligible if there is no evidence of
             progression or hemorrhage after treatment of the brain metastasis/metastases

          -  Prior treatment for CNS disease as deemed appropriate by the treating physician

          -  ECOG performance status 0, 1, or 2

          -  Measurable or evaluable disease

          -  Use of an accepted and effective method of contraception (hormonal or barrier methods,
             abstinence) prior to study entry and for the duration of the study (for women of
             childbearing potential and sexually active men)

        Exclusion Criteria:

          -  Prior chemotherapy for metastatic disease

          -  Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus
             radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle 1

          -  Extrathoracic metastases as the only sites of disease

          -  Active malignancy other than lung cancer

          -  Current, recent, or planned participation in another experimental drug study

          -  Untreated brain metastases

          -  Presence of intrathoracic lesion(s) with any cavitation

          -  Gross hemoptysis within 3 months prior to Day 1

          -  In the opinion of the investigator or local radiologist, evidence of tumor that is
             extending into the lumen of a major blood vessel

          -  Inadequately controlled hypertension

          -  Unstable angina or NYHA Grade II or greater CHF

          -  Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
             months prior to Day 1

          -  Myocardial infarction within 6 months prior to Day 1, Cycle 1

          -  Stroke within 6 months prior to Day 1, Cycle 1

          -  Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1

          -  History of significant vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Current, ongoing treatment with full-dose warfarin or its equivalent

          -  Current or recent use of aspirin (>325 mg/day)

          -  Known hypersensitivity to any components of bevacizumab

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  UPC ratio ≥ 1.0

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during
             the course of the study

          -  Pregnancy or lactation

          -  Inadequate organ function

          -  Any other medical conditions (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, or participate in the study, or to interfere with the
             interpretation of the results