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
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Efficacy assessment: ORR
Condition
Adenocarcinoma of Lung
Intervention
CT-16
Study Arms / Comparison Groups
CT-P16
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
689
Start Date
December 19, 2018
Completion Date
August 2023
Primary Completion Date
April 22, 2021
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03676192
Organization ID
CT-P16 3.1
Responsible Party
Sponsor
Study Sponsor
Celltrion
Study Sponsor
, ,
Verification Date
August 2022