CompletedPhase 3NCT02810457

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

StatusCompleted
PhasePhase 3
U.S. locations147
SponsorCentus Biotherapeutics Limited
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

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.

04
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.

View original record ↗