To Compare Efficacy and Safety of CT-P16 and European Union-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Phase 3

Completed

• Conditions: Adenocarcinoma of Lung
• Interventions: Drug: CT-P16; Drug: Avastin

• Registration Number: NCT03676192
• Lead Sponsor: Celltrion

Brief Summary

To demonstrate that CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by objective response rate (ORR) during the Induction Study Period

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-16
• Study First Posted: 2018-09-18
• Study Start: 2019-02-01
• Primary Completion: 2021-04-22
• Study Completion: 2023-09-19
• Results First Submitted: 2024-04-19
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Results First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 689

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 non-squamous non-small cell lung cancer (nsNSCLC)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P16	CT-P16	Drug: Bevacizumab 15mg/kg IV of CT-P16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until Progressive Disease (PD) or intolerable toxicity during the Maintenance Period.
Avastin	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) During the Induction Study Period From Central Review	Induction Study Period (around 18 weeks)	The ORR was defined as the proportion of patients with a confirmed Best Overall Response (BOR) of CR or PR (the 'responder'). All other patients except responders were considered as non-responders, including patients without post-baseline tumor assessment.

Secondary Outcome Measures

Name	Time	Method
Response Duration From Central Review	Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.	Response duration was defined as time between initial response (CR or PR) that is confirmed by the subsequent assessment after study treatment administration and PD/recurrence or death from any cause, whichever occurs first.
Time to Progression From Central Review	Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.	Time to progression was defined as time from randomization to determined PD/recurrence.
Progression Free Survival From Central Review	Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.	Progression-free survival was defined as time from randomization to determined PD/recurrence or death from any cause, whichever occurs first.
Overall Survival	Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.	Overall survival was defined as time from randomization to death from any cause.
Trough Serum Concentrations During the Induction Study Period	Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period.	Pharmacokinetic samples were collected on Day 1 of each cycle (prior to the beginning of the study drug administration) in the Induction Study Period.
Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period	Immunogenicity was assessed Day 1 of Cycle 1 (predose), every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, EOT visit, and at the first visit of Follow-up period.	Immunogenicity was assessed on Day 1 of Cycle 1 (pre-dose), every 2 cycles during the Induction Study Period, and every 3 cycles during the Maintenance Study Period and End of Treatment (EOT) visit. In the Follow-Up Period, immunogenicity was assessed once at the first visit of the Follow-Up Period (ninth week).

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of