NCT03240549

Effectiveness and Safety of Adding Bevacizumab to First Line Chemotherapy in Lung Cancer Patients With Stable Disease

Effectiveness and Safety of Adding Bevacizumab to Chemotherapy in Patients With Advanced Lung Adenocarcinoma With Stable Disease After 2 Cycles of First Line Combination Chemotherapy: a Multicenter, Prospective Cohort Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.

Detailed description

Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis. So a prospective cohort study has been designed to confirm this hypothesis, patients with advanced pulmonary adenocarcinoma who are stable after two cycles of platinum-based combination chemotherapy are objects of this study, and they can choose to continue the previous treatment regimen according to the guideline or adding bevacizumab to the regimen independently until the progression or intolerance of toxicity, or 4 to 6 cycles of chemotherapy in stable disease. The objective response rate in these two groups who received different treatment is the primary endpoint and the toxicity, quality of life, the progression free survival are the second endpoints.

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	bevacizumab	The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-08-31
• Completion: 2019-09-30
• First posted: 2017-08-07
• Last updated: 2017-08-07

Regulatory

• FDA-regulated drug study