Conditions: Non-Small Cell Lung Cancer Brain Neoplasms
Keywords: Brain Cancer Brain Metastases Avastin NSCLC Lung Cancer PASSPORT
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 115
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: bevacizumab intervention 2: First-Line Chemotherapy Agents intervention 3: Second-Line Chemotherapy Agents
Intervention descriptions: intervention 1: 15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be \< 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity. intervention 2: Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily.

All agents were dosed and administered per institutional standards using the respective package insert as a guideline. intervention 3: Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued.

All agents were dosed and administered per institutional standards using the respective package insert as a guideline.

Protocol document: