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



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:September 7, 2016
End Date:February 2022

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A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients With Advanced/Recurrent Non Squamous NSCLC in Combination of Paclitaxel and Carboplatin

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


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 EGFR mutations or 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.
We found this trial at
12
sites
Joliet, Illinois 60435
Phone: 815-730-3098
578
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from
Joliet, IL
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Brest, Brestskaya voblasts 22402
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Brest,
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Canton, Ohio 44708
Phone: 330-489-1274
902
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Canton, OH
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Canton, Ohio 44718
Phone: 330-492-3345
902
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Canton, OH
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Fountain Valley, California 92708
1160
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from
Fountain Valley, CA
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Houston, Texas 77090
Phone: 877-870-2640
569
mi
from
Houston, TX
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Jacksonville, Florida 32204
Phone: 904-427-1217
1054
mi
from
Jacksonville, FL
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895
mi
from
Massillon, OH
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744
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Minot, ND
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Olympia, Washington 98502
Phone: 360-352-2900
1422
mi
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Olympia, WA
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Skokie, Illinois 60076
Phone: 847-675-3900
610
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from
Skokie, IL
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Whittier, California 90603
Phone: 562-693-4477
1158
mi
from
Whittier, CA
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