Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

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

Details

• Lead Sponsor: Centus Biotherapeutics Limited
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Patients aged 18 years or older

• Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease

• Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC

• Existence of at least 1 measurable lesion by RECIST v1.1

• Adequate hematological, renal and liver function

• Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1

• Life expectancy longer than 6 months

Exclusion Criteria:

• Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature

• Any unresolved toxicities from prior systemic therapy

• Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation positive mutations

• Previous dosing with vascular endothelial growth factor (VEGF) inhibitor

• Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy

• Use of prohibited concomitant medication

• Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection

• Fertile men or women of childbearing potential not using adequate contraception.

Other inclusion/exclusion criteria may apply.