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Trial record 1 of 1 for:    NCT03676192
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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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ClinicalTrials.gov Identifier: NCT03676192
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Celltrion

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2018)
Efficacy assessment: ORR [ Time Frame: Primary efficacy endpoint-Induction Study Period (around 21 weeks) ]
Objective Response Rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of Lung
Intervention  ICMJE
  • Drug: CT-16
    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.
  • Drug: Avastin
    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.
Study Arms  ICMJE
  • Experimental: CT-P16
    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.
    Intervention: Drug: CT-16
  • Active Comparator: Avastin
    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: Drug: Avastin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 21, 2020)
690
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2018)
678
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03676192
Other Study ID Numbers  ICMJE CT-P16 3.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celltrion
Study Sponsor  ICMJE Celltrion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: SangJoon Lee CELLTRION, Inc.
PRS Account Celltrion
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP