Clinical Trial: NCT03676192
To Compare Efficacy and Safety of CT-P16 and European Union-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Celltrion |
| Information Provided By: | Celltrion |
| Last Update Posted: | 2025-03-17 |
Study Overview
Brief Summary
To demonstrate that CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by objective response rate (ORR) during the Induction Study Period
Official Title
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
Conditions
Adenocarcinoma of Lung
Intervention / Treatment
- Drug: CT-P16
- Drug: Avastin
Other Study ID Numbers
- CT-P16 3.1
Start Date (Actual)
2019-02-01
Primary Completion Date (Actual)
2021-04-22
Study Completion Date (Actual)
2023-09-19
Enrollment (Actual)
689
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Celltrion |
| Information Provided By: | Celltrion |
| Last Update Posted: | 2025-03-17 |
Study Overview
Brief Summary
To demonstrate that CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by objective response rate (ORR) during the Induction Study Period
Official Title
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
Conditions
Adenocarcinoma of Lung
Intervention / Treatment
- Drug: CT-P16
- Drug: Avastin
Other Study ID Numbers
- CT-P16 3.1
Start Date (Actual)
2019-02-01
Primary Completion Date (Actual)
2021-04-22
Study Completion Date (Actual)
2023-09-19
Enrollment (Actual)
689
Study Type
Interventional
Phase
Phase 3