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

Use our guide to learn which trials are right for you!

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
Brest, Brestskaya voblasts 22402
?
mi
from 91732
Brest,
Click here to add this to my saved trials
Canton, Ohio 44708
Phone: 330-489-1274
2047
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Canton, Ohio 44718
Phone: 330-492-3345
2047
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Houston, Texas 77090
Phone: 877-870-2640
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32204
Phone: 904-427-1217
2128
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Joliet, Illinois 60435
Phone: 815-730-3098
1701
mi
from 91732
Joliet, IL
Click here to add this to my saved trials
2039
mi
from 91732
Massillon, OH
Click here to add this to my saved trials
1303
mi
from 91732
Minot, ND
Click here to add this to my saved trials
Olympia, Washington 98502
Phone: 360-352-2900
931
mi
from 91732
Olympia, WA
Click here to add this to my saved trials
Skokie, Illinois 60076
Phone: 847-675-3900
1726
mi
from 91732
Skokie, IL
Click here to add this to my saved trials
Whittier, California 90603
Phone: 562-693-4477
6
mi
from 91732
Whittier, CA
Click here to add this to my saved trials