Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
NCT Number: NCT05169801
This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Nanjing, Jiangsu, 210000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BP102, paclitaxel, carboplatin
Avastin®, paclitaxel, carboplatin
Time frame: 18 weeks
optimal ORR at 18 weeks, independent radiographic assessment
Time frame: 41 months
Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: 41 months
Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.
Time frame: 41 months
Based on investigator reviewed radiographic tumour assessment and death.
Time frame: 41 months
Based on investigator reviewed radiographic tumour assessment and death.
Time frame: 41 months
Evaluate subjects' quality of life
Time frame: Enrollment to 28 days after permanent treatment termination
Safety analyses will be performed using the safety population, defined as all patients receiving any study drug.
Time frame: 41 months
Immunogenicity evaluation
Time frame: 41 months
Immunogenicity evaluation
Jiangsu HengRui Medicine Co., Ltd.
Industry
To Compare the Efficacy and Safety of BP102 in Combination With Paclitaxel/Carboplatin and Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC - a Randomized, Double-blind, Positive Parallel Control, Multicentre Phase III Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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