Clinical trial · Interventional
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
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
NCT03676192CI-TRIAL-00087280completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Drug | Bevacizumab | ALIAS |
| CT-P16 | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CT-P16
- description
- 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.
- interventionNames
- Drug: CT-P16
- type
- ACTIVE_COMPARATOR
- label
- Avastin
- description
- 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.
- interventionNames
- Drug: Avastin
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) During the Induction Study Period From Central Review
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (3)
- DERIVEDKim T, Kim H, Lee H, Ahn K, Park T, Baek H, Chang MJ. Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin(R) and US-Avastin(R) in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. BioDrugs. 2026 Aug 2. doi: 10.1007/s40259-026-00800-1. Online ahead of print. PMID 42542998
- DERIVEDAndric 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. PMID 40795416
- DERIVEDVerschraegen 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. PMID 36169807