A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2018-10-09
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Bioepis Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

Criteria

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.