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

Sponsor
Beijing Hospital
Study ID
NCT03240549
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.

Study Details

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.

Key Dates

First listed
Aug 7, 2017
Start date
Aug 31, 2017
Status verified
Aug 2017
Primary completion
Aug 31, 2018
Completion
Sep 30, 2019

Study Design

Enrollment
159 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: conventional therapy group
    Treatment with previous regimen of combined chemotherapy
  • Experimental: bevacizumab group
    Adding bevacizumab to the previous regimen of combined chemotherapy

Primary Outcome Measure

Objective Response Rate [ Time Frame: Assessment of the response should be done from the written consent to the 3 month after the last patient inrolled in the study, assessed up to 24 months. ]

Central Contacts

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