Clinical trial · Interventional
A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
NCT02754882CI-TRIAL-00083746completedPhase 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)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| SB8 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab (Avastin)
- description
- Avastin® + Carboplatin/Paclitaxel
- interventionNames
- Drug: Bevacizumab
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- SB8 (A proposed bevacizumab biosimilar)
- description
- SB8 + Carboplatin/Paclitaxel
- interventionNames
- Drug: SB8
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 years 2. ECOG performance status of 0-1 3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer 4. At least one measurable lesion according to RECIST v1.1. 5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters Exclusion Criteria: 1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma 2. Sensitizing EGFR mutations or ALK rearrangements 3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings 4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
References
Publications (0)
Data not yet available
No reference posted for this study.