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NCT03676192 Clinical Trial

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

Adenocarcinoma of Lung Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data
NCT number NCT03676192
Other study ID # CT-P16 3.1
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 19, 2018
Est. completion date August 2023

Study information
Verified date August 2022
Source Celltrion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 689
Est. completion date August 2023
Est. primary completion date April 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Korea, Republic of Chung-Ang University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy assessment: ORR Objective Response Rate Primary efficacy endpoint-Induction Study Period (around 21 weeks)
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