None listed
Conditions
Interventions
Bevacizumab-Pfizer and bevacizumab-EU are clear, colorless to pale brown liquid in a glass vial with a rubber stopper. Each 20 mL glass vial contains 400 mg of bevacizumab in 16 ml of solution.
On
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient eligibility should be reviewed and documented by an appropriate member of the investigator’s study team before patients are included in the study. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Male and female patients age ≥18 years of age, or ≥ age of consent in the region. 2. Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC) for which they had not received chemotherapy for metastatic disease. 3. Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC. 4. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ...(See Printed Dossier)
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the study: 1. Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature. 2. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation. 3. Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations. 4. History of other cancer within 5 years prior to screening for this study, with the exception of adequately treated ductal carcinoma in situ of the breast, cervical carcinoma in situ, or basal or squamous cell skin cancer. 5. Prior systemic therapy for metastatic disease. ...(See Printed Dossier)
Countries
Argentina, Australia, Brazil, Canada, Chile, Germany, India, Italy, Japan, Mexico, Peru, Portugal, Russian Federation, Spain, United States
Contacts
Public ContactCarla Olivera
PFIZER S.A.
Outcome results
None listed