Clinical trial NCT03676192: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adenocarcinoma of Lung
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Objective Response Rate (ORR) During the Induction Study Period From Central Review
timeFrame: Induction Study Period (around 18 weeks)
Secondary outcomes:
measure: Response Duration From Central Review
timeFrame: 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.
measure: Time to Progression From Central Review
timeFrame: 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.
measure: Progression Free Survival From Central Review
timeFrame: 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.
measure: Overall Survival
timeFrame: 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.
measure: Trough Serum Concentrations During the Induction Study Period
timeFrame: Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period.
measure: Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period
timeFrame: 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.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
citation: Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Park S, Ju H, Ohe Y. Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. BioDrugs. 2022 Nov;36(6):749-760. doi: 10.1007/s40259-022-00552-8. Epub 2022 Sep 28.