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Brief Title: A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer
Official Title: A Phase III Study Comparing Efficacy and Safety of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer
Study ID: NCT03533127
Brief Summary: This is a Randomized, Double-blind, Multicenter Phase III Study Comparing Efficacy and Safety of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Bevacizumab Combined with Paclitaxel and Carboplatin for Treatment of Naïve Subjects with Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer
Detailed Description: The objectives are to compare the efficacy, safety and immunogenicity of LY01008 and bevacizumab combined with paclitaxel and carboplatin for treatment of subjects with metastatic or recurrent nonsquamous non-small cell lung cancer. The subjects will receive the treatment with LY01008 or bevacizumab combined with paclitaxel and carboplatin for 4-6 cycles, and then both groups of subjects will receive the maintenance monotherapy with LY01008 until occurrence of progressive disease (PD), intolerable toxicity reaction, withdrawal of informed consent, loss to follow-up, death, conduct of other antineoplastic therapy or completion of the whole study. The doses of LY01008 and bevacizumab are 15 mg/kg in combination therapy. The dose of LY01008 in maintenance monotherapy is 15 mg/kg.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chinese Academy of Medical Sciences, Chaoyang, Beijing, China