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

Completed · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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

Key facts

Study ID

NCT02810457

Run by

Centus Biotherapeutics Limited

People needed

731

Starts

2016-09-07

Expected to finish

2022-01-26

Last updated by the study team

2022-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site 7811 - Innovative Clinical Research Institute — Whittier, California, United States
• Research Site 7803 - 21st Century Oncology — Jacksonville, Florida, United States
• Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Research Site 7810 - Edward H. Kaplan, MD and Associates — Skokie, Illinois, United States
• Research Site 7813 - Trinity Cancer Care Center — Minot, North Dakota, United States
• Research Site 7805 - Hematology & Oncology Associates, Inc. — Canton, Ohio, United States
• Research Site 7801 - Gabrail Cancer Center — Canton, Ohio, United States
• Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc. — Massillon, Ohio, United States
• Research Site 7809 - Millennium Oncology — Houston, Texas, United States
• Research Site 7806 - Vista Oncology Inc. PS — Olympia, Washington, United States
• Research Site 8507 — Brest, Brest Oblast, Belarus
• Research Site 8505 — Grodno, Hrodzenskaya Voblasts, Belarus
• Research Site 8501 — Lyasny, Minsk Oblast, Belarus
• Research Site 8504 — Minsk, Minsk Oblast, Belarus
• Research Site 8502 — Mogilev, Mogilyov Oblast, Belarus
• Research Site 8506 — Vitebsk, Vitebsk Oblast, Belarus
• Research Site 8605 — Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina
• Research Site 8606 — Banja Luka, Bosnia and Herzegovina
• Research Site 8602 — Mostar, Bosnia and Herzegovina
• Research Site 8601 — Sarajevo, Bosnia and Herzegovina
• Research Site 8603 — Sarajevo, Bosnia and Herzegovina
• Research Site 8604 — Zenica, Bosnia and Herzegovina
• Research Site 0905 — Sofia, Dobrich, Bulgaria
• Research Site 0904 — Varna, Bulgaria
• Research Site 7814 - Compassionate Care Research Group — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.