A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)

Genentech

Status and phase

Completed

Phase 2

Conditions

Brain Neoplasms

Non-Small Cell Lung Cancer

Treatments

Drug: Second-Line Chemotherapy Agents

Drug: First-Line Chemotherapy Agents

Drug: bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00312728

AVF3752g

Details and patient eligibility

About

This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent
Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma
Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
Appropriateness for first- or second-line systemic therapy for advanced NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age ≥ 18 years
For women of childbearing potential and sexually active males, use of an accepted and effective method of contraception (e.g., hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study

Exclusion criteria

Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1
Progressive neurologic symptoms
Active malignancy other than lung cancer
Current, recent, or planned participation in an experimental drug study
Prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms
Gross hemoptysis within 3 months prior to Day 1
Inadequately controlled hypertension
Unstable angina or New York Heart Association Grade II or greater congestive heart failure (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
Stroke within 6 months prior to Day 1
Active symptomatic peripheral vascular disease within 6 months prior to Day 1
History of significant vascular disease
Evidence of bleeding diathesis or coagulopathy
Known hypersensitivity to any components of bevacizumab
Inadequate organ function
Serious non-healing wound, ulcer, or bone fracture
Urine protein/creatinine (UPC) ratio of ≥ 1.0
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
Pregnancy or lactation
Known evidence of disseminated intravascular coagulation (DIC)
Active infection or fever > 38.5°C within 3 days prior to Day 1
Any other medical condition (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results