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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03676192
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Celltrion

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

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Lung Drug: CT-16 Drug: Avastin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Efficacy assessment: ORR [ Time Frame: Primary efficacy endpoint-Induction Study Period (around 21 weeks) ]
    Objective Response Rate



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676192


Contacts
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Contact: EnDa Ko +82328505754 EnDa.Ko@celltrion.com
Contact: MoonSun Choi +82328505757 MoonSun.Choi@@celltrion.com

Locations
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Korea, Republic of
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Principal Investigator: Joung Soon Jang, MD         
Sponsors and Collaborators
Celltrion
Investigators
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Study Director: SangJoon Lee CELLTRION, Inc.

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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03676192     History of Changes
Other Study ID Numbers: CT-P16 3.1
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors