A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Genentech, Inc.
- Enrollment
- 115
- Primary Endpoint
- Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
bevacizumab
Intervention: bevacizumab
bevacizumab
Intervention: First-Line Chemotherapy Agents
bevacizumab
Intervention: Second-Line Chemotherapy Agents
Outcomes
Primary Outcomes
Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage
Time Frame: From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)
The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage. Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death
Secondary Outcomes
- Overall Survival (OS) in First-line Setting(Time from enrollment to death from any cause (up to 2 years))
- Number of Participants With Overall Survival (OS) in First-line Setting [1-Year or More Survival](Time from enrollment to death from any cause (up to 2 years))
- OS in First-line and Second-line Settings(Time from enrollment to death from any cause (up to 2 years))
- Number of Participants With OS in First-line and Second-line Settings [1-Year or More Survival](Time from enrollment to death from any cause (up to 2 years))
- Number of Participants With Selected Adverse Events(From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years))