Clinical Trials /

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

NCT03676192

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CT-P16 3.1
  • NCT ID: NCT03676192

Conditions

  • Adenocarcinoma of Lung

Interventions

DrugSynonymsArms
CT-16CT-P16
AvastinAvastin

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CT-P16ExperimentalDrug: 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.
  • CT-16
AvastinActive ComparatorDrug: 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.
  • Avastin

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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy assessment: ORR
Time Frame:Primary efficacy endpoint-Induction Study Period (around 21 weeks)
Safety Issue:
Description:Objective Response Rate

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celltrion

Last Updated