Phase 3
N=763
A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Lung Cancer · Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02754882 ↗Enrolled (actual)
763
Serious AEs
20.6%
Results posted
Dec 2024
Primary outcome: Primary: Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks — 42.8; 47.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Drug); SB8 (Drug); Carboplatin (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Samsung Bioepis Co., Ltd.
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks |
42.8; 47.6 | — |
| SECONDARY Progression Free Survival |
8.50; 7.90; 8.50; 7.90 | — |
| SECONDARY Overall Survival |
14.90; 15.80; 14.80; 15.80 | — |
| SECONDARY Duration of Response (DoR) |
6.38; 6.79; 6.33; 6.81 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 |
348; 346; 47; 57; 127; 134 | — |
| SECONDARY Pharmacokinetics: Trough Level [Ctrough] |
0.0000; 0.0000; 83.7568; 102.3939; 109.0906; 119.9343 | — |
| SECONDARY Pharmacokinetics: Maximum Plasma Concentration [Cmax] |
306.0352; 302.6362; 374.9657; 399.4598; 389.3132; 397.6183 | — |
| SECONDARY Immunogenicity Assessments (Anti-drug Antibodies) |
15; 15; 357; 356; 0; 0 | — |
| SECONDARY Immunogenicity Assessments (Neutralizing Antibodies) |
0; 1; 15; 14; 9; 9 | — |
Summary
This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria
- Aged ≥ 18 years
- ECOG performance status of 0-1
- Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
- At least one measurable lesion according to RECIST v1.1.
- Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters
Exclusion Criteria
- Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
- Sensitizing EGFR mutations or ALK rearrangements
- Increased risk of bleeding determined by investigator based on radiographic / clinical findings
- History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
Data sourced from ClinicalTrials.gov (NCT02754882). 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.