Phase 3
N=689
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
Adenocarcinoma of Lung
Bottom Line
View on ClinicalTrials.gov: NCT03676192 ↗Enrolled (actual)
689
Serious AEs
20.6%
Results posted
Mar 2025
Primary outcome: Primary: Objective Response Rate (ORR) During the Induction Study Period From Central Review — 42.40; 42.07 percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P16 (Drug); Avastin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celltrion
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) During the Induction Study Period From Central Review |
42.40; 42.07 | — |
| SECONDARY Response Duration From Central Review |
0.60; 0.56; 0.17; 0.25; 0.09; 0.10 | — |
| SECONDARY Time to Progression From Central Review |
0.83; 0.81; 0.29; 0.34; 0.11; 0.11 | — |
| SECONDARY Progression Free Survival From Central Review |
0.73; 0.71; 0.23; 0.28; 0.08; 0.09 | — |
| SECONDARY Overall Survival |
0.66; 0.62; 0.35; 0.34; 0.19; 0.21 | — |
| SECONDARY Trough Serum Concentrations During the Induction Study Period |
50426.3; 52515.7; 73127.7; 81533.7; 93100.6; 95878.8 | — |
| SECONDARY Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period |
81; 90; 12; 11 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03676192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.