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

Centus Biotherapeutics

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Carboplatin; Drug: FKB238 (bevacizumab); Drug: Avastin (bevacizumab); Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02810457

2015-004104-33 (EudraCT Number)

FKB238-002

Details and patient eligibility

About

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

Enrollment: 731 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

731 participants in 2 patient groups

FKB238 / paclitaxel / carboplatin

Experimental group

Description:

Drug: FKB238: 15 mg/kg IV infusion on Day 1 of each 21-day cycle. Drug: Paclitaxel: 200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles. Drug: Carboplatin: Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.

Treatment:

Drug: Paclitaxel

Drug: FKB238 (bevacizumab)

Drug: Carboplatin

Avastin / paclitaxel / carboplatin

Active Comparator group

Description:

Drug: Avastin: 15 mg/kg IV infusion on Day 1 of each 21-day cycle. Drug: Paclitaxel: 200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles. Drug: Carboplatin: AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.

Treatment:

Drug: Paclitaxel

Drug: Avastin (bevacizumab)

Drug: Carboplatin