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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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

678

Start Date

December 19, 2018

Completion Date

August 2023

Primary Completion Date

January 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

          -  has known central nervous system metastases

          -  had surgery for metastatic nsNSCLC
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

SangJoon Lee, +82328505754, [email protected]

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

SangJoon Lee, Study Director, CELLTRION, Inc.


Verification Date

July 2019