Phase 3
Completed N=731
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT02810457 ↗Enrolled (actual)
731
Serious AEs
25.6%
Results posted
Mar 2020
Primary outcomePrimary: Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR) — 51.6; 53.7 percentage of participants
◆ Published Evidence
Established
22citations · ~4 / year
Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC).
Summary
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
Linked Publications
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Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR) |
51.6; 53.7 | — |
| SECONDARY ORR at Week 19 |
47.8; 51.0 | — |
| SECONDARY Progression-free Survival (PFS) |
7.72; 7.62 | — |
| SECONDARY Overall Survival (OS) |
14.13; 16.95 | — |
| SECONDARY Duration Of Response (DOR) |
6.47; 6.31 | — |
| SECONDARY Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED |
87.6; 87.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02810457) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.