drugset / 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
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2019-02-01
- Primary completion
- 2021-04-22
- Completion
- 2023-09-19
Outcome
Met primary endpoint
paper The risk difference (0.40 [95% CI - 7.02 to 7.83]) and risk ratio (1.0136 [90% CI 0.8767-1.1719]) for ORR fell within predefined equivalence margins PMID 36169807 ↗
release “The therapeutic equivalence of CT-P16 and reference bevacizumab was demonstrated by way of objective response rate (ORR) during the induction study period.” celltrion.com ↗
Publications
- Andric Z, Moiseenko F, Makharadze T, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Ju H, Baek EH, Kwon S, Chang I, Kim S, Kim H, Lee E, Verschraegen C. Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer. Cancer Treat Res Commun. 2025;44:100970. doi: 10.1016/j.ctarc.2025.100970. Epub 2025 Jul 24.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | CT-P16 | Monoclonal antibody | 15 mg/kg | Intravenous |