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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFKB238 (bevacizumab) and Avastin (bevacizumab)

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 10, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?147 U.S. locations

Locations may change over time.

Who runs it?Centus Biotherapeutics Limited

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Recurrent or relapsed→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

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.

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