Back to resultsTo 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
Primary Purpose
Adenocarcinoma of Lung
Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT-16
Avastin
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Lung
Eligibility Criteria
Inclusion Criteria:
- diagnosed as recurrent disease or stage IV
- has at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1
Exclusion Criteria:
- has predominantly squamous cell histology non-small cell lung cancer
- had surgery for metastatic nsNSCLC
Sites / Locations
- Chung-Ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT-P16
Avastin
Arm Description
Drug: Bevacizumab 15mg/kg IV of CT-16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period.
Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period.
Outcomes
Primary Outcome Measures
Efficacy assessment: ORR
Objective Response Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03676192
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To demonstrate that CT-P16 is similar to US-approved Avastin in terms of efficacy determined by overall response rate (ORR) up to Cycle 6 during the Induction Study Period
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
689 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P16
Arm Type
Experimental
Arm Description
Drug: Bevacizumab 15mg/kg IV of CT-16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period.
Arm Title
Avastin
Arm Type
Active Comparator
Arm Description
Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period.
Intervention Type
Drug
Intervention Name(s)
CT-16
Intervention Description
15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period.
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period.
Primary Outcome Measure Information:
Title
Efficacy assessment: ORR
Description
Objective Response Rate
Time Frame
Primary efficacy endpoint-Induction Study Period (around 21 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as recurrent disease or stage IV
has at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1
Exclusion Criteria:
has predominantly squamous cell histology non-small cell lung cancer
had surgery for metastatic nsNSCLC
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
36169807
Citation
Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Park S, Ju H, Ohe Y. Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. BioDrugs. 2022 Nov;36(6):749-760. doi: 10.1007/s40259-022-00552-8. Epub 2022 Sep 28.
Results Reference
derived
Learn more about this trial
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
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