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

Samsung

Status and phase: Completed; Phase 3

Conditions: Non-small Cell Lung Cancer; Lung Cancer

Treatments: Drug: SB8; Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02754882

SB8-G31-NSCLC

Details and patient eligibility

About

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).

Full description

Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.

Enrollment: 763 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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763 participants in 2 patient groups

Bevacizumab (Avastin)

Active Comparator group

Description:

Avastin® + Carboplatin/Paclitaxel

Treatment:

Drug: Bevacizumab

Drug: Paclitaxel

Drug: Carboplatin

SB8 (A proposed bevacizumab biosimilar)

Experimental group

Description:

SB8 + Carboplatin/Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: SB8