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

Sponsor

Celltrion (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03676192

Collaborator

(none)

690

Enrollment

Location

Arms

55.4

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Dec 19, 2018

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

Efficacy assessment: ORR [Primary efficacy endpoint-Induction Study Period (around 21 weeks)]
Objective Response Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ang University Hospital	Seoul		Korea, Republic of	06973

Sponsors and Collaborators

Celltrion

Investigators

Study Director: SangJoon Lee, CELLTRION, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celltrion

ClinicalTrials.gov Identifier:

NCT03676192

Other Study ID Numbers:

CT-P16 3.1

First Posted:

Sep 18, 2018

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma of Lung

Bevacizumab

Study Results

No Results Posted as of Oct 22, 2020