At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 689 enrolled
Drug / intervention
CT-P16 +1 moredrug
Likely dose
CT-P16 15mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CT-P16 and Avastin for Adenocarcinoma of Lung. Completed, enrolled 689 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of Lung
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartFeb 2019
Primary CompletionApr 2021
Study CompletionSep 2023
TodayJul 2026
First PostedSep 18, 2018
Enrollment StartFeb 1, 2019
Primary CompletionApr 22, 2021
Study CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.8 years ago
Interventions
CT-P16drug
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.
Avastindrug
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.