Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
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
Checked against the public recordLast updated Mar 10, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Centus Biotherapeutics Limited
- Interventions being studied
- Drug: FKB238 (bevacizumab); Drug: Avastin (bevacizumab); Drug: Paclitaxel; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research Site 7814 - Compassionate Care Research GroupFountain Valley, California
- Research Site 7811 - Innovative Clinical Research InstituteWhittier, California
- Research Site 7803 - 21st Century OncologyJacksonville, Florida
- Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd.Joliet, Illinois
- Research Site 7810 - Edward H. Kaplan, MD and AssociatesSkokie, Illinois
- Research Site 7813 - Trinity Cancer Care CenterMinot, North Dakota
- Research Site 7805 - Hematology & Oncology Associates, Inc.Canton, Ohio
- Research Site 7801 - Gabrail Cancer CenterCanton, Ohio
- Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc.Massillon, Ohio
- Research Site 7809 - Millennium OncologyHouston, Texas
- Research Site 7806 - Vista Oncology Inc. PSOlympia, Washington
- Research Site 8507Brest, Brest Oblast
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 10, 2022. Always confirm current availability with the study team.