Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT 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.
Study:
NCT03533127
Study Brief:
Protocol Section:
NCT03533127