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

C

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

Trial documents
2

Trial contacts and locations

147

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Data sourced from clinicaltrials.gov

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