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 |
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
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
Massillon, Ohio 44646
Phone: 330-489-1274
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Joliet, Illinois 60435
Phone: 815-730-3098
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Whittier, California 90603
Phone: 562-693-4477
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