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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

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 690 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

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Arms and Interventions
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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.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (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
  • had surgery for metastatic nsNSCLC
Contacts and Locations
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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


Locations
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Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of, 06973
Sponsors and Collaborators
Celltrion
Investigators
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Study Director: SangJoon Lee CELLTRION, Inc.
More Information
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03676192    
Other Study ID Numbers: CT-P16 3.1
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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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 of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Adenocarcinoma
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