Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer NSCLC Preoperative chemotherapy Bevacizumab Avastin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Detailed description:
Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy. At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%). However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated. Many of these patients will subsequently be eligible for resection (bimodality therapy). The rationale for this multicenter, Phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\>4.0 cm), II, and select stage III NSCLC. This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Arms:
arm 1: Preoperative chemotherapy and bevacizumab

Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel intervention 3: Bevacizumab
Intervention descriptions: intervention 1: Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64 intervention 2: Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64 intervention 3: Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)

Protocol document: